Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma (BERT)
This is a multicenter, open label, single arm, phase I/II study. There will be no placebo usage within this trial.
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.
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.
|Follicular Lymphoma Mantle Cell Lymphoma||Drug: Temsirolimus, Rituximab, Bendamustin||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Phase I: MTD / Phase II: ORR [ Time Frame: Phase I: 2 months (start cycle 3), Phase II: 6 months ]phase II: ORR is evaluated approx. 6 weeks after end of treatment
- Progression free survival [ Time Frame: at 2 years ]for part II only
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: single arm
Bendamustin, Rituximab, Temsirolimus
Drug: Temsirolimus, Rituximab, Bendamustin
Temsirolimus 25 - 50 - 75mg, day 1,8,15 Bendamustin 90/m2, day 1,2 Rituximab 375/m2, day 1 Phase II at established dose, repeat day 28-42 (max)
Other Name: Mabthera, Rituxan, Torisel, Bendamustin, Ribomustin, Trenda
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078142
|Mainz, Rheinland-Pfalz, Germany, 55131|
|Principal Investigator:||Georg Hess, MD||Department of Hematology, Oncology and Pneumology, Universitätsmedizin der Johannes Gutenberg-Universität, Mainz, Germany|