T-cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.
Objectives: Primary - To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy Secondary - To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT - To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) - To estimate the toxicity (grade 3 and above) - To estimate the rate of successful stem cell mobilization after CHOEP in responding patients - To estimate the proportion of patients who can successfully complete the entire treatment regimen - To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT - To determine whether tumor DNA can be detected in peripheral blood of patients before therapy - To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00992446 -
Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT04774068 -
Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
|
Phase 1 | |
| Completed |
NCT03263637 -
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT05377827 -
Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies
|
Phase 1 | |
| Completed |
NCT01919619 -
Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies
|
Phase 2 | |
| Completed |
NCT03061188 -
Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma
|
Phase 1 | |
| Completed |
NCT03833180 -
A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
|
Phase 1 | |
| Terminated |
NCT03195010 -
Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia
|
Phase 2 | |
| Completed |
NCT00723099 -
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Completed |
NCT02424968 -
CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05127135 -
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
|
Phase 1 | |
| Completed |
NCT00880815 -
Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant
|
Phase 1 | |
| Active, not recruiting |
NCT03333486 -
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
|
Phase 2 | |
| Recruiting |
NCT02859402 -
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
|
Phase 2 | |
| Recruiting |
NCT04594135 -
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
|
Phase 1 | |
| Recruiting |
NCT04934774 -
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
|
Phase 1 |