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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: MTD / Phase II: ORR
phase II: ORR is evaluated approx. 6 weeks after end of treatment
Phase I: 2 months (start cycle 3), Phase II: 6 months
Georg Hess, MD
Department of Hematology, Oncology and Pneumology, Universitätsmedizin der Johannes Gutenberg-Universität, Mainz, Germany
Germany: Federal Institute for Drugs and Medical Devices