BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)

Related Clinical Trial
Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product. Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma Study of SGR-1505 in Mature B-Cell Neoplasms Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL Zanubrutinib in Patients With Waldenström’s Macroglobulinemia (ARIADNE) Treatment of Chinese Patients With B-Cell Malignancies With BGB-16673, a Burton Tyrosine Kinase-Targeted Protein-Degrader Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia Loncastuximab Tesirine in WM HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer A Phase 1 Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies Efficacy of Venetoclax in Combination With Rituximab in Waldenström’s Macroglobulinemia Spanish Registry of Patients With IgM Monoclonal Gammopathies ACALA-R In Anti-MAG Neuropathy Mediated Neuropathy Study of Oral LOXO-338 in Patients With Advanced Blood Cancers NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies 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

BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)

Official Title

A Phase I, Open-label, Multi-center, Dose Escalation, and Expansion Study of BR101801 in Adult Patients With Advanced Hematologic Malignancies

Brief Summary

      This is a Phase I-II, multi-center, open-label, FIH study comprising of 2 study parts (Phase
      Ia, Phase Ib).

      The Phase Ia (dose escalation) part of the study is designed to determine the safety,
      tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RP2D) of
      BR101801 in subjects with relapsed/refractory B cell lymphoma, chronic lymphocytic leukemia
      (CLL)/small lymphocytic leukemia (SLL), and peripheral T cell lymphoma (PTCL).

      The Phase Ib (dose expansion) part of the study is designed to assess tumor response and
      safety in specific advanced relapsed/refractory Peripheral T-cell lymphoma(PTCL) at a dose of
      BR101801 identified in Phase Ia. Once the RP2D has been determined in Phase Ia (dose
      escalation), Phase Ib (dose expansion) will commence.
    

Detailed Description

      1. Phase Ia (Dose Escalation)

           Primary Objectives

             -  To assess the safety and tolerability of BR101801 in patients with
                relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL.

             -  To assess DLT and to determine the MTD and/or the RDE dose for BR101801 when
                administered orally on a daily schedule in 4-week cycles until disease progression.

           SecondaryObjectives

             -  To characterize the plasma and urine PK of BR101801.

             -  To assess the preliminary antitumor activity of BR101801.

        2. Phase Ib (Dose Expansion)

      Primary Objectives

      • To assess the safety and tolerability of BR101801 at the RP2D dose in subjects with
      relapsed/refractory Peripheral T-cell lymphoma (PTCL).

      SecondaryObjectives

        -  To assess clinical activity of BR101801 when administered orally on a daily schedule in
           4-week cycles until disease progression.

        -  To assess the plasma PK of BR101801.

      OUTLINE: This is a Phase I, multi-center, open-label, FIH study. The safety monitoring
      committee(SMC) will be responsible for safety oversight.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

To determination of the MTD and RDE based on DLTs during Cycle 1 (Phase Ia )

Secondary Outcome

 Cmax

Condition

Diffuse Large B Cell Lymphoma

Intervention

BR101801 (Phase Ia)

Study Arms / Comparison Groups

 Treatment (BR101801): Phase Ia (dose escalation)
Description:  Patients will receive BR101801 capsules orally, QD in 28-day cycles. The regimen may be changed to BID dosing based on emerging data.

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

30

Start Date

April 21, 2020

Completion Date

March 2024

Primary Completion Date

December 2023

Eligibility Criteria

        

          1. Patients must sign an informed consent document

          2. Female or male patients aged ≥ 18 years.

          3. ECOG performance status ≤ 2.

          4. Life expectancy more than 3 months.

          5. Phase Ia:Patients with relapsed and/or refractory relapsed/refractory B-cell lymphoma,
             CLL/SLL, and PTCL diagnosed with World Health Organization (WHO) classification

          6. Phase Ib: Subjects with PTCL NOS, PTCL AITL, Nodal PTCL with TFH and PTCL FTCL.

          7. Patients have measurable disease based on the appropriate tumor type criteria( Phase
             Ib only)

          8. Have a current need for systemic therapy, the assessment of the investigator.

          9. An archival or fresh tumor tissue (ie, tissue block or series of at least 5 slides, up
             to 15 slides) is required and should be provided during the Screening Visit for
             Lymphoma subjects. Local review of pathology is required for study entry in Phase Ib
             only.

         10. Phase Ia subjects should be prepared to undergo a fresh tumor biopsy during the study
             (tumor biopsies will be obtained from 1 to 2 subjects per cohort in Phase Ia).

         11. Subject having laboratory values defined as:

               -  Creatinine clearance (measured or calculated per institutional standard practice)
                  ≥ 60 mL/min. GFR can also be used in place of creatinine clearance.

               -  Total bilirubin < 1.5 × ULN, except for subjects with Gilbert's syndrome who are
                  excluded if total bilirubin > 3.0 × ULN or direct bilirubin < 1.5 × ULN.

               -  ALT < 2.5 × ULN, except for subjects who have tumor involvement of the liver, who
                  are included if ALT < 5 × ULN.

               -  AST < 2.5 × ULN, except for subjects that have tumor involvement of the liver,
                  who are included if AST < 5 × ULN.

               -  Absolute neutrophil count > 1.0 × 109/L.

               -  Platelet count > 75 × 109/L.

               -  Hemoglobin > 8 g/dL.

        

          1. Presence of overt leptomeningeal or active CNS metastases, or CNS metastases that
             require local CNS-directed therapy or increasing doses of corticosteroids within the
             prior 2 weeks. Patients with treated brain metastases should be neurologically stable
             and off steroids for at least 2 weeks before administration of any study treatment.

          2. Impaired cardiac function or clinically significant cardiac disease

          3. Patients with interstitial pneumonia or history of drug-induced interstitial
             pneumonia/pneumonitis.

          4. Human immunodeficiency virus (HIV) infection.

          5. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B core
             antibody (HBcAb), or hepatitis C virus antibody (HCVAb).

          6. Chronic liver disease or chronic hepatitis

          7. Any gastrointestinal disorders interfering with study drug absorption or are unable to
             swallow tablets or capsules.

          8. Malignant disease, other than that being treated in this study.

          9. Prior PI3K inhibitor will be accepted in the dose escalation part of the study (Phase
             Ia) only.

         10. For patients with lymphoma:

               -  Systemic antineoplastic therapy (including cytotoxic chemotherapy,
                  alfa-interferon [INF], and toxin immunoconjugates) or any experimental therapy
                  within 3 weeks or 5 half lives, whichever is shorter, before the first dose of
                  study treatment.

               -  Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose
                  of study treatment.

               -  Unconjugated monoclonal antibody therapies < 6 weeks before the first dose of
                  study treatment.

         11. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy
             (≥ 10 mg/day prednisone or equivalent).

         12. Use of any live vaccines against infectious diseases within 4 weeks of initiation of
             study treatment.

         13. Use of hematopoietic colony-stimulating growth factors, thrombopoietin mimetics, or
             erythroid-stimulating agents ≤ 2 weeks prior to start of study drug.

         14. Patients with a history of stroke or having active neurological symptoms, with the
             exception of chronic conditions which, in the opinion of the neurologist,
             Investigator, and the Sponsor, would not impact ongoing neurologic assessments while
             on study treatment.

         15. Active infection requiring systemic or antiviral antibiotic therapy.

         16. Subjects with active CMV infection.

         17. Subjects receiving moderate or potent CYP3A4 inhibitors or inducers and are unable to
             withdraw until 2 weeks or 5 times longer than the half-life, whichever is shorter,
             before the first dose of study treatment.

         18. Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy,
             insertion of a central venous access device, and insertion of a feeding tube are not
             considered major surgery).

         19. Radiotherapy within 2 weeks of the first dose of study treatment, except for
             palliative radiotherapy to a limited-field, such as for the treatment of bone pain or
             a focally painful tumor mass.

         20. Presence of CTCAE ≥ Grade 2 toxicity (except alopecia, peripheral neuropathy, and
             ototoxicity, which are excluded if ≥ CTCAE Grade 3) due to prior cancer therapy.

         21. Participation in an interventional, investigational study within 2 weeks or 5
             half-lives, whichever is shorter, of the first dose of study treatment.

         22. Any medical condition that would, in the Investigator's judgment, prevent the
             subject's participation in the clinical study due to safety concerns, compliance with
             clinical study procedures, or interpretation of study results.

         23. Pregnant or lactating women, where pregnancy is defined as the state of a female after
             conception and until the termination of gestation, confirmed by a positive human
             chorionic gonadotropin laboratory test.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

TM Kim, M.D, Ph.D, +82-2-708-8204, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT04018248

Organization ID

BR-101801-CT-101


Responsible Party

Sponsor

Study Sponsor

Boryung Pharmaceutical Co., Ltd


Study Sponsor

TM Kim, M.D, Ph.D, Principal Investigator, Seoul National University Hospital


Verification Date

January 2023