Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Trial to Evaluate the Safety, Feasibility and Efficacy of the Addition of Temsirolimus to a Regimen of Bendamustine and Rituximab for the Treatment of Patients With Follicular Lymphoma or Mantle Cell Lymphoma in First to Third Relapse
This is a multicenter, open label, single arm, phase I/II study. There will be no placebo
usage within this trial.
Phase I:
Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen
of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle
cell lymphoma.
Phase II:
Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT
dose Secondary: To determine the complete remission rate, progression free survival rate and
overall survival rate and to investigate safety and tolerability of BERT.
The first part of the study is a phase I study in which the maximum tolerated dose of the
combination of Temsirolimus, Bendamustine and Rituximab will be established. In the phase I
part of the trial 3 patients will be included in each dose level. After inclusion of 3
patients, each patient has to receive at least 2 complete cycles without DLT until the
enrolment into the next cohort can be initiated. In case of one DLT, 3 additional patients
will be added to the specific dose level. If a second DLT appears, the last dose level
without DLT will be considered the standard dose for the phase II trial. If the third dose
level is achieved without any DLT, there will be no further dose escalation.
In the phase II proportion of the trial, after establishment of a maximum tolerated dose, the
efficacy of the combination regimens in two different patient cohorts will be evaluated. In
the one cohort, 30 patients with relapsed mantle cell lymphoma will be treated; the second
cohort will be composed of 30 patients with relapsed follicular lymphoma.
;
| 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 |
NCT03891355 -
Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL
|
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 | |
| 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 |