Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Evaluation of Bendamustine, Obinutuzumab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
This phase II trial studies how well bendamustine, obinutuzumab, and venetoclax work in treating patients with mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bendamustine, obinutuzumab, and venetoclax may work better in treating patients with mantle cell lymphoma.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of bendamustine, obinutuzumab and venetoclax in patients with untreated mantle cell lymphoma. SECONDARY OBJECTIVES: I. To evaluate the safety and dose intensity of the combination of bendamustine, obinutuzumab and venetoclax in untreated mantle cell lymphoma. II. To explore methods of determining molecular remission for patients with untreated mantle cell lymphoma (MCL). III. To evaluate long-term outcomes including progression-free and overall survival for patients with untreated MCL who receive the combination. OUTLINE: Patients receive venetoclax orally (PO) on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine intravenously (IV) on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. After completion of study treatment, patients are followed up at 45-60 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
| Recruiting |
NCT05976763 -
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
|
Phase 3 | |
| Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
| Recruiting |
NCT05471843 -
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05076097 -
A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03891355 -
Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL
|
Phase 2 | |
| Recruiting |
NCT04883437 -
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
|
Phase 2 | |
| Terminated |
NCT03585725 -
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
|
Early Phase 1 | |
| Recruiting |
NCT02892695 -
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Completed |
NCT01665768 -
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
|
Phase 2 | |
| Completed |
NCT01437709 -
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT00963534 -
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
|
Phase 1/Phase 2 | |
| Completed |
NCT00921414 -
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
|
Phase 3 | |
| Withdrawn |
NCT00541424 -
Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma
|
N/A | |
| Completed |
NCT01456351 -
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
|
Phase 3 | |
| Completed |
NCT01851551 -
Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
|
Phase 1/Phase 2 | |
| Completed |
NCT03295240 -
The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma
|
Early Phase 1 |