Peripheral T-cell Lymphoma Clinical Trial
Official title:
PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study
The goal of this clinical trial is to determine the maximum tolerated dose (MTD) of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma (PTCL), and to compare the combination of linperlisib and chidamide to standard CHOP (cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone) regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better.
In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the optimal dose of linperlisib. In the phase II trial, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP regimen chemotherapy. Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00038025 -
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
|
Phase 2 | |
| Recruiting |
NCT02445404 -
Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL
|
Phase 2 | |
| Completed |
NCT02168140 -
CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
|
Phase 1 | |
| Completed |
NCT01689220 -
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
|
Phase 1 | |
| Terminated |
NCT01644253 -
Phase 1b Safety and Efficacy Study of TRU-016
|
Phase 1 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT01435863 -
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
|
Phase 1 | |
| Terminated |
NCT00441025 -
The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
|
Phase 2 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00003196 -
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
|
N/A | |
| Active, not recruiting |
NCT04312841 -
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab
|
Phase 2 | |
| Recruiting |
NCT04040491 -
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
|
Phase 4 | |
| Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT02264613 -
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
|
Phase 1/Phase 2 | |
| Completed |
NCT02142530 -
Carfilzomib Plus Belinostat in Relapsed/Refractory NHL
|
Phase 1 | |
| Terminated |
NCT01408043 -
Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
|
N/A | |
| Completed |
NCT00131937 -
Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT00791947 -
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
|
Phase 2 | |
| Recruiting |
NCT04880746 -
Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
|
Phase 3 |