Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trial
Official title:
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13
This is a randomized, open label, phase III study to evaluate the ability of rituximab
maintenance therapy to prolong event-free survival in aggressive NHL.
Patients will be screened after successful standard induction therapy (CR or Cru following
standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8
cycles). Patients will be followed until an event occurs as defined in the protocol. To
evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation
in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who
have achieved a complete remission after appropriate first-line therapy, measured by
event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm)
will be recruited.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06043011 -
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
|
||
| Not yet recruiting |
NCT05532761 -
Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells
|
||
| Not yet recruiting |
NCT05596097 -
Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission
|
Phase 2 | |
| Terminated |
NCT02914938 -
A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT02570542 -
Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
|
Phase 2 | |
| Terminated |
NCT00482053 -
Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT
|
Phase 2 | |
| Active, not recruiting |
NCT04049513 -
ENABLE (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy)
|
Phase 1 | |
| Recruiting |
NCT05364424 -
A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma
|
Phase 1 | |
| Terminated |
NCT02983097 -
Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP
|
Phase 1/Phase 2 | |
| Completed |
NCT00001337 -
Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT04830137 -
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
|
Phase 1 | |
| Recruiting |
NCT03547115 -
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML
|
Phase 1 | |
| Completed |
NCT04933617 -
Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
|
Phase 1 | |
| Not yet recruiting |
NCT04767308 -
Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
|
Early Phase 1 | |
| Recruiting |
NCT04836507 -
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05583149 -
Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas
|
Phase 2 | |
| Terminated |
NCT02957019 -
A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
|
Phase 1/Phase 2 | |
| Completed |
NCT02445248 -
Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients
|
Phase 2 | |
| Withdrawn |
NCT04456023 -
Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)
|
Phase 2 | |
| Recruiting |
NCT06256484 -
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
|
Phase 1 |