Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

Related Clinical Trial
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas Immune Responses to COVID-19 Vaccination in Lymphoma Patients Testing the Addition of a New Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies Covid-19 Vaccine Responsiveness in MM and Waldenstrom Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies. Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19) Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma Bendamustine, Rituximab and Acalabrutinib in Waldenstrom’s Macroglobulinemia CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma 19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers Zanubrutinib, Ixazomib and Dexamethasone in Patients With Treatment Naive Waldenstrom’s Macroglobulinemia A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia or B-Cell Prolymphocytic Leukemia Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease Bendamustine Plus Rituximab Versus CHOP Plus Rituximab Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma TLR9 Agonist SD-101, Anti-OX40 Antibody BMS 986178, and Radiation Therapy in Treating Patients With Low-Grade B-Cell Non-Hodgkin Lymphomas Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies Copanlisib and Nivolumab in Treating Participants With Richter’s Transformation or Transformed Indolent Non-Hodgkin’s Lymphoma Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme Malignancies UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep Allo HSCT Using RIC for Hematological Diseases Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma Safety and Tolerability of HSC835 in Patients With Hematological Malignancies T-Regulatory Cell and CD3 Depleted Double Umbilical Cord Blood Transplantation in Hematologic Malignancies Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma Bortezomib and Fludarabine With or Without Rituximab in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia Alvocidib, Fludarabine Phosphate, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction Monoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin’s Lymphoma Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin’s Lymphoma or T-cell Lymphoma Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin’s Lymphoma or Hodgkin’s Disease Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma Study of MLN8237 in Participants With Advanced Hematological Malignancies 3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin’s Lymphoma With or Without Impaired Liver or Kidney Function Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin’s Lymphoma 17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkin’s or Non-Hodgkin’s Lymphoma MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas 17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma Rituximab in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma Gossypol, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders FAU in Treating Patients With Advanced Solid Tumors or Lymphoma Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma Vorinostat in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma and Liver Dysfunction Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma PXD101 and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas Dose Monitoring of Busulfan and Combination Chemotherapy in Hodgkin or Non-Hodgkin Lymphoma Undergoing Stem Cell Transplant Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies Genetically Modified Peripheral Blood Stem Cell Transplant in Treating Patients With HIV-Associated Non-Hodgkin or Hodgkin Lymphoma Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukemia, or Lymphoma Vorinostat and Lenalidomide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma Lenalidomide And Rituximab as Maintenance Therapy in Treating Patients With B-Cell Non-Hodgkin Lymphoma Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas CPI-613, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Bortezomib and Filgrastim in Promoting Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Stem Cell Transplant A Long-term Extension Study of PCI-32765 (Ibrutinib) Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies The Master Registry of Oncology Outcomes Associated With Testing and Treatment Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Alisertib in Combination With Vorinostat in Treating Patients With Relapsed or Recurrent Hodgkin Lymphoma, B-Cell Non-Hodgkin Lymphoma, or Peripheral T-Cell Lymphoma Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin’s Lymphoma Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies Nonmyeloablative Allogeneic Transplant Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Non-Hodgkin Lymphoma Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab—Phase I Trial in Indolent B-cell Lymphoma A Phase II Study of Doxycycline in Relapsed NHL Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin’s Lymphoma Imexon for Relapsed Follicular and Aggressive Lymphomas Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators’ Expression in Allogeneic SCT Using FluBuATG Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas Trial of AVN-944 in Patients With Advanced Hematologic Malignancies A Pilot Study of the Safety and Activity of Escalating Doses of ON 01910.Na in Patients With Relapsed Mantle Cell Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, and Related Lymphoid Malignancies Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas Nivolumab and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma Pembrolizumab and Ibrutinib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance. Rifaximin in Patients With Monoclonal Gammopathy Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer A Phase 1 Dose-Escalation and Cohort-Expansion of VLS-101 in Hematologic Malignancies 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin’s Lymphoma After Autologous Stem Cell Transplantation A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma B-Cell Hematologic Malignancy Vaccination Registry Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies (CLOVER-1) Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm’s Macroglobulinemia BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I) A Study of ARQ 531 in Patients With Selected Hematologic Malignancies Ibrutinib + Venetoclax in Untreated WM Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders Ibrutinib and Ixazomib Citrate in Treating Participants With Relapsed or Refractory Waldenstrom Macroglobulinemia The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma A Phase II Study of Carfilzomib in Relapsed Waldenström’s Macroglobulinemia (WM) IST-CAR-531 Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin’s Lymphoma Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS. A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies A Phase I Trial of DI-B4 in Patients With Advanced CD19 Positive Indolent B-cell Malignancies Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors Bortezomib and Rituximab for Patients With Waldenstrom’s Macroglobulinemia Bortezomib, Dexamethasone, and Rituximab in Untreated Waldenstroms Macroglobulinemia Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma Everolimus (RAD001) in Primary Therapy of Waldenstrom’s Macroglobulinemia Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom’s Macroglobulinemia Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom’s Macroglobulinemia Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom’s Macroglobulinemia APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom’s Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4 Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom’s Macroglobulinemia Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL) A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström’s Macroglobulinemia A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström’s Macroglobulinemia (WM) A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom’s Macroglobulinemia (WM) A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1 Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom Macroglobulinemia A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia Efficacy of Carfilzomib in Combination With Ibrutinib in Waldenström’s Macroglobulinemia Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström’s Macroglobulinemia Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström’s Macroglobulinaemia Extension Study of IMO-8400 in Patients With Waldenström’s Macroglobulinemia Who Completed Study 8400-401 DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom’s Macroglobulinemia Patients Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom’s Macroglobulinemia Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström’s Macroglobulinemia (WM) Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström’s Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

Official Title

A Phase I/II Study of Syk Inhibitor Entospletinib (GS-9973) in Combination With Obinutuzumab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-Cell Malignancies

Brief Summary

      This phase I/II trial studies the side effect and best dose of entospletinib when giving
      together with obinutuzumab and to see how well they work in treating patients with chronic
      lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that has come back.
      Entospletinib may stop the growth of cancer cells by blocking some of the enzymes need for
      cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of
      cancer cells to grow and spread. Giving entospletinib and obinutuzumab together may work
      better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or
      non-Hodgkin lymphoma.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the safety and tolerability of entospletinib administered in combination with
      obinutuzumab in patients with relapsed/refractory chronic lymphocytic leukemia/small
      lymphocytic lymphoma (CLL/SLL) and non-Hodgkin lymphoma (NHL), and identify the dose for
      phase 2 expansion. (Phase I) II. To evaluate the efficacy of entospletinib in combination
      with obinutuzumab in patients with relapsed or refractory CLL/SLL, as measured by complete
      response (CR) rate. (Phase II)

      SECONDARY OBJECTIVES:

      I. Objective response rate (ORR, defined as complete remission, complete response with
      incomplete marrow recovery, partial remission and nodular partial response). (Phase II) II.
      Event free survival defined as the interval between the date of first study treatment and the
      date of objective signs of disease recurrence, subsequent anti-leukemic therapy, or death,
      whichever is first reported. (Phase II) III. Safety and tolerability of entospletinib in
      combination with obinutuzumab by adverse events (AEs). (Phase II)

      EXPLORATORY OBJECTIVES:

      I. Peripheral blood B-cell depletion and recovery. II. Pharmacodynamics effects of in vivo
      administration of entospletinib on NFkappaB activation and expression of anti-apoptotic
      proteins in CLL cells.

      III. Association of established biomarkers (chromosomal abnormalities, immunoglobulin heavy
      chain [IGHV] mutational status, p53 mutational status) with response (ORR and event-free
      survival [EFS]) to entospletinib (ENTO) in combination with obinutuzumab in patients with
      relapsed/refractory CLL.

      OUTLINE: This is a phase I, dose-escalation study of entospletinib followed by a phase II
      study.

      Patients receive entospletinib orally (PO) either once a day (QD) or twice a day (BID) on
      days -7 to -1 (run-in phase) depending on the assigned dose level. Patients also receive
      obinutuzumab intravenously (IV) on days 1, 2, 8, and 15 of the first cycle and on day 1 of
      all subsequent cycles. Treatment with obinutuzumab repeats every 28 days for up to 6 cycles
      and daily treatment with entospletinib continues every 28 days for up to 12 cycles in the
      absence of disease progression or unexpected toxicity.

      After completion of study treatment, patients are followed up every 3 months for 12 months
      then every 6 months thereafter. In the event of study closure, patients who are receiving
      study drug at the time of closure will complete an abbreviated End of Treatment (EOT) visit.
      No additional follow up will occur.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum tolerated dose (MTD) and/or a recommended phase II dose (Phase I)

Secondary Outcome

 Objective response rate (ORR) (Phase II)

Condition

Anemia

Intervention

Entospletinib

Study Arms / Comparison Groups

 Treatment (entospletinib, obinutuzumab)
Description:  Patients receive entospletinib PO either QD or BID on days -7 to -1 (run-in phase) depending on the assigned dose level. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of the first cycle, and on day 1 of subsequent cycles. Treatment with obinutuzumab repeats every 28 days for up to 6 cycles and daily treatment with entospletinib continues every 28 days for up to 12 cycles in the absence of disease progression or unexpected toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

July 17, 2017

Completion Date

April 29, 2021

Primary Completion Date

April 29, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Phase I portion of the study: Histologically or flow cytometry confirmed diagnosis of
             B-CLL/SLL according to National Cancer Institute (NCI)-Working Group (WG) 1996
             guidelines

          -  Phase I portion of the study: The following types of NHL as documented by medical
             records and with histology based on criteria established by the World Health
             Organization (WHO):

               -  Mantle cell lymphoma (MCL)

               -  Follicular lymphoma (FL) - grades 1-3a

               -  Lymphoplasmacytic lymphoma (LPL)

               -  Marginal zone lymphoma (MZL)

               -  CLL in Richter's transformation

               -  B-cell prolymphocytic leukemia

          -  Phase I portion of the study: Patients with histologically confirmed classical hairy
             cell leukemia (HCL)

          -  Phase II portion of the study - histologically or flow cytometry confirmed diagnosis
             of BCLL/SLL according to NCI-WG 1996 guidelines; patients who lack CD23 expression on
             their leukemia cells should be examined for (and found NOT to have) either t(11;14) or
             cyclin D1 overexpression, to rule out mantle cell lymphoma

          -  Patients underwent >= 1 prior chemotherapy-based or immunotherapy-based regimen or
             targeted therapy (e.g., inhibitors of BTK, PI3K etc.) administered for >= 2 cycles,
             and have had either documented disease progression or no response (stable disease) to
             the most recent treatment regimen

          -  Patients with CLL/SLL must demonstrate active disease meeting at least 1 of the
             International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for
             requiring treatment:

               -  A minimum of any one of the following constitutional symptoms:

                    -  Unintentional weight loss > 10% within the previous 6 months prior to
                       screening

                    -  Extreme fatigue (unable to work or perform usual activities)

                    -  Fevers of greater than 100.5 Fahrenheit (F) for >= 2 weeks without evidence
                       of infection

                    -  Night sweats without evidence of infection

               -  Evidence of progressive marrow failure as manifested by the development of, or
                  worsening of anemia or thrombocytopenia

               -  Massive (i.e., > 6 cm below the left costal margin), progressive or symptomatic
                  splenomegaly

               -  Massive nodes or clusters (i.e., > 10 cm in longest diameter) or progressive
                  lymphadenopathy

               -  Progressive lymphocytosis with an increase of > 50% over a 2-month period, or an
                  anticipated doubling time of less than 6 months

               -  Autoimmune anemia or thrombocytopenia that is poorly responsive to
                  corticosteroids

          -  Patients with HCL must be intolerant of or not candidates for purine analog-based
             therapy, or failed to achieve response (CR or partial response [PR]) or relapsed
             within 2 years of such therapy, AND meet the standard treatment initiation criteria
             (absolute neutrophil count [ANC] =< 1000/uL, hemoglobin [Hgb] =< 10 g/dL, platelet
             count =< 100,000/uL); patients with indolent lymphoma (FL, LPL, MZL) and patients with
             B-cell prolymphocytic leukemia must have an indication for treatment in the opinion of
             the investigator; patients with MCL and patients with CLL in Richter's transformation
             should have previously received or not be candidates for high dose
             chemotherapy/autologous stem cell transplant

          -  For diseases other than CLL, LPL, and HCL, presence of radiographically measurable
             lymphadenopathy or extra-nodal lymphoid malignancy (defined as the presence of >= 1
             lesion that measures >= 2.0 cm in the longest dimension [LD] and >= 1.0 cm in the
             longest perpendicular dimension [LPD] as assessed by computed tomography [CT] or
             magnetic resonance imaging [MRI]); for LPL, measurable disease will be defined as
             serum monoclonal IgM > 0.5 g/dL or meeting at least 1 of the recommendations from the
             Second International Workshop on LPL for requiring treatment

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Direct bilirubin =< 2 X institutional upper limit of normal (ULN) (unless due to known
             Gilbert's syndrome or compensated hemolysis directly attributable to CLL)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 X
             institutional ULN

          -  Estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation >= 50 mL/min

          -  Platelets >= 50,000/mm^3 independent of transfusion support, with no active bleeding

          -  Absolute neutrophil count (ANC) >= 1000/mm^3, unless due to disease involvement in the
             bone marrow

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Prior therapeutic intervention with any of the following:

               -  Therapeutic anticancer antibodies within 4 weeks (rituximab), except within 6
                  months for obinutuzumab or a similar investigational type II monoclonal antibody;

               -  Radio- or toxin-immunoconjugates within 10 weeks;

               -  Inhibitors of BTK (ibrutinib), PI-3K (idelalisib), BH3-mimetic venetoclax,
                  lenalidomide and other "targeted" therapy (including but not limited to
                  investigational BTK and PI-3K inhibitors, etc.) - within 6 half-lives (i.e., 36
                  hours for ibrutinib)

               -  All other chemotherapy, radiation therapy within 3 weeks prior to initiation of
                  therapy

               -  SYK inhibitors at any time

          -  Inadequate recovery from adverse events related to prior therapy to grade =< 1
             (excluding grade 2 alopecia and neuropathy)

          -  Chronic use of corticosteroids in excess of prednisone 30 mg/day or its equivalent

          -  Stem cell transplant recipients must have no evidence of and not receive treatment for
             graft-versus-host disease

          -  Concomitant use or use in the prior two weeks of moderate or strong CYP3A and CYP2C9
             inducers or strong CYP2C9 inhibitors, including nutraceutical preparations, e.g.,
             grapefruit juice and St John's wort

          -  History prior malignancy except:

               -  Malignancy treated with curative intent and no known active disease present for
                  >= 2 years prior to initiation of therapy on current study

               -  Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ)
                  without evidence of disease

               -  Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without
                  evidence of disease

               -  Asymptomatic prostate cancer managed with "watch and wait" strategy

               -  Myelodysplastic syndrome which is clinically well controlled and no evidence of
                  the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow
                  at screening

          -  Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test
             in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)

          -  History of human immunodeficiency virus (HIV) infection or active hepatitis B or C

          -  Major surgery (requiring general anesthesia) within 2 weeks prior to initiation of
             therapy

          -  Inability to swallow and retain an oral medication; patients with clinically
             significant medical condition of malabsorption, inflammatory bowel disease, chronic
             conditions which manifest with diarrhea, refractory nausea, vomiting or any other
             condition that will interfere significantly with drug absorption are excluded;
             patients must also have adequate venous access

          -  Need for ongoing therapy with proton pump inhibitors; H2 antagonists are allowed

          -  Active uncontrolled infection

          -  Women who are pregnant or lactating

          -  Fertile men or women of childbearing potential unless 1) permanently sterile or 2)
             using a highly effective measure of contraception such as condoms in males and
             consistent and correct use of one of the following in females: intrauterine device,
             tubal sterilization, Essure micro-insert system, vasectomy in the male partner;
             effective contraception is required for males during treatment with study drug and to
             continue for 3 months after the last dose of either entospletinib or obinutuzumab,
             whichever is later; for women, effective contraception is required to continue for 18
             months after the last dose of obinutuzumab or for 30 days after the last dose of
             entospletinib, whichever is later

               -  Definition of childbearing potential: for this study, a female subject is
                  considered of childbearing potential until becoming post-menopausal unless
                  permanently sterile or with medically documented ovarian failure; women are
                  considered to be in a postmenopausal state when >= 54 years of age with cessation
                  of previously occurring menses for >= 12 months without an alternative cause;
                  women of any age with amenorrhea of >= 12 months may also be considered
                  post-menopausal if their follicle stimulating hormone (FSH) level is in the
                  post-menopausal range and they are not using hormonal contraception or hormonal
                  replacement therapy; permanent sterilization in females includes hysterectomy,
                  bilateral oophorectomy, or bilateral salpingectomy in a female subject of any
                  age; permanent sterilization in males include bilateral orchiectomy or medical
                  documentation of alternative explanation

          -  Any condition for which participation in the study is judged by the Investigator to be
             detrimental to the patient with inter-current illness or psychiatric/social situations
             that would jeopardize compliance with study requirements
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Craig Okada, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03010358

Organization ID

STUDY00016140

Secondary IDs

NCI-2016-02029

Responsible Party

Sponsor-Investigator

Study Sponsor

Alexey Danilov, MD

Collaborators

 Gilead Sciences

Study Sponsor

Craig Okada, M.D., Principal Investigator, OHSU Knight Cancer Institute


Verification Date

April 2021