Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas

Learn more about:
Related Clinical Trial
A Phase 1, Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma. A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas AMG 319 Lymphoid Malignancy FIH Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies Tandem Auto-Allo Transplant for Lymphoma Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies. p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas CD4CAR for CD4+ Leukemia and Lymphoma Pembrolizumab for T/NK-cell lymphomasNK-cell Lymphomas Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma A Study for Patients With Non-Hodgkin’s Lymphomas High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma Allo-HSCT as First-line Consolidation in High-risk PTCL A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed /Refractory Hodgkin Lymphoma, Mature T-cell Lymphoma and Multiple Myeloma. (RId Study) A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low ( T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL) Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL) Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL) ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas Phase I Dose-finding and Preliminary Efficacy Study of the Istodax® in Combination With Doxil® for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL) CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia A Multicenter Clinical Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin in Patients With Relapsed/Refractory CD38 Positive PTCL-NOS, Angioimmunoblastic T-cell Lymphoma AITL and Other Nodal Lymphomas of T Follicular Helper Cells Origin Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin’s Lymphoma HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma Gemcitabine in NK/T Cell Lymphoma A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma Trial of Endostar Combined With CHOPT for T Cell Lymphoma Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

Brief Title

Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas

Official Title

Phase II Trial With Safety Lead in of Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas

Brief Summary

      The investigators hypothesize that duvelisib maintenance after autologous stem cell
      transplant with carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning in
      patients with T-cell lymphomas, or a history of indolent B-cell lymphomas, will be safe and
      well tolerated, and will improve progression free survival.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free survival (PFS)

Secondary Outcome

 Safety and tolerabilty as measured by number of study treatment related adverse events

Condition

T-Cell Lymphoma

Intervention

Duvelisib

Study Arms / Comparison Groups

 Duvelisib Maintenance
Description:  Patients who received the standard BEAM regimen with autologous hematopoietic stem cells transplant will begin duvelisib maintenance at 25 mg PO BID after count recovery (approximately 30 days after transplant) for one year. If the patient is in a complete remission at day +100, with no evidence of disease on PET/CT, then the dosing schedule of duvelisib may be changed to 25 mg BID for 14 days, then 14 days off in 28 day cycles (at the treating physician's discretion). If the patient has residual disease, duvelisib will continue at 25 mg BID until they have a negative PET CT. PET CTs will be completed every 3 months for patients with residual disease. Duvelisib maintenance will be continued for one year post-transplant.
Starting on 06/10/2021, all new participants will be enrolled to take 25 mg BID of duvelisib on days 1-14 of a 28 day cycle.

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

36

Start Date

July 23, 2020

Completion Date

July 31, 2025

Primary Completion Date

July 31, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of T cell non-Hodgkin lymphoma, or indolent B cell non-Hodgkin lymphoma.
             B-cell histologies include follicular, CLL/SLL, lymphoplasmacytic, or marginal zone
             lymphomas, and include transformed to aggressive B-cell lymphoma. T cell lymphomas
             included are peripheral T cell lymphoma not otherwise specified, angioimmunoblastic T
             cell lymphoma, and systemic anaplastic large cell lymphoma.

          -  Eligible for autologous stem cell transplantation as determined by the treating
             physician or completed BEAM autologous transplant within the last 30 days.

          -  At least 18 years of age at time of enrollment

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Adequate organ function as defined below:

               -  Serum creatinine ≤ 1.5 times institutional upper limit of normal (IULN)

               -  Total bilirubin ≤ 1.5 x IULN. Patients with Gilbert's Syndrome may have a
                  bilirubin > 1.5 x IULN

               -  Hemoglobin ≥ 8.0 g/dL

               -  Absolute neutrophil count ≥ 1.0 x 109/L

               -  Platelet count ≥ 75 x 109/L

               -  AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

          -  Women of childbearing potential and men must agree to use highly effective
             contraception prior to study entry and for the duration of study participation and for
             3 months after the last dose of duvelisib. Negative serum β human chorionic
             gonadotropin (βHCG) pregnancy test within 7 days before first treatment is required if
             the patient is a woman of childbearing potential.

          -  Participants or a participant's legally authorized representative must be able to
             understand and willing to sign an IRB approved written informed consent document

        Exclusion Criteria:

          -  Currently receiving any other experimental therapy or has received experimental
             therapy within 4 weeks prior to study treatment

          -  History of allergic reaction attributed to compounds of similar chemical or biologic
             composition to duvelisib or other agents used in the study.

          -  Prior history of drug-induced colitis or drug-induced pneumonitis

          -  History of concurrent interstitial lung disease or severely impaired lung function

          -  History of chronic liver disease or veno-occlusive disease

          -  History of tuberculosis within 2 years prior to enrollment

          -  Administration of a live or live attenuated vaccine within 6 weeks of first duvelisib
             dose

          -  Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic
             steroids > 20 mg of prednisone (or equivalent) per day

          -  Ongoing treatment for systemic bacterial, fungal, or viral infections at screening.

        Note: patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically
        excluded is all other inclusion/exclusion criteria are met

          -  Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV),
             or herpes zoster (VZV) at screening

          -  Infection with HBV, HCV. Subjects with a positive HBsAg or HCV Ab on pre-transplant
             infection screening will be excluded. Subjects with a positive HBcAb must have
             negative HBV DNA to be eligible and must be periodically monitored for HBV
             reactivation by institutional guidelines.

          -  Baseline QTcF > 500 milliseconds. This does not apply to subjects with right or left
             bundle branch blocks

          -  Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ
             of the cervix, bladder cancer, or prostate cancer not requiring treatment.

          -  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

          -  Concurrent administration of medications or foods that are strong inhibitors or
             inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start
             of study intervention.

          -  Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects
             with detectable viral load)

          -  History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
             requiring medication or a pacemaker within the last 6 months prior to screening.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable
             cardiac arrhythmia.

          -  Pregnant or breastfeeding.

          -  Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or
             they have a history of AIDS-defining opportunistic infection within the 12 months
             prior to registration. Concurrent treatment with effective ART according to DHHS
             treatment guidelines is recommended. Recommend exclusion of specific ART agents based
             on predicted drug-drug interactions (i.e. concurrent strong CYP3A4 inhibitors
             (ritonavir and cobicistat) or inducers (efavirenz) are contraindicated).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Amanda Cashen, M.D., 314-454-8323, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04331119

Organization ID

202005165


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine

Collaborators

 SecuraBio

Study Sponsor

Amanda Cashen, M.D., Principal Investigator, Washington University School of Medicine


Verification Date

June 2021