Peripheral T-cell Lymphoma Clinical Trial
Official title:
Phase I Dose-Escalation Study of Azacitidine (Vidaza) and Bortezomib (Velcade) in T-Cell Lymphoma
RATIONALE: Bortezomib and azacitidine may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when
given together with azacitidine in treating patients with relapsed or refractory T-cell
lymphoma.
PRIMARY OBJECTIVES I. To determine the maximum tolerated dose (MTD) of VELCADE (BORTEZOMIB)
in combination with Azacitidine in patients with relapsed/refractory CTCL/PTCL.
II. To define the specific toxicities and the dose-limiting toxicity (DLT) of VELCADE
(BORTEZOMIB) in combination with Azacitidine.
SECONDARY OBJECTIVES I. To determine the overall response rate (ORR). II. To correlate the
biological activity of Azacitidine as a demethylating agent (changes in target gene
methylation and gene expression, DNMT1 protein expression, global methylation) with clinical
endpoints and plasma pharmacokinetics of Azacitidine.
III. To characterize the biological activity of VELCADE (BORTEZOMIB) as a potential
demethylating agent.
IV. To correlate intracellular concentration of Azacitidine-triphosphate with global DNA
methylation and other biological endpoints as well as clinical response.
V. To explore the biologic role of microRNAs in determining clinical response to the VELCADE
(BORTEZOMIB) plus Azacitidine combination and achievement of the other pharmacodynamic
endpoints.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive bortezomib IV on days 4, 8, 11, and 15 and azacitidine subcutaneously (SC)
on days 1-5. Treatment repeats every 28 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment patients are followed up for at least 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 | |
| Terminated |
NCT01644253 -
Phase 1b Safety and Efficacy Study of TRU-016
|
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 | |
| 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 |