Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma

Sponsor
Georg Hess, MD
Study ID
NCT01078142
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temsirolimus, Rituximab, Bendamustin — DRUG
    Phase I: 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)

Study Details

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.

Key Dates

Start date
Feb 2, 2010
Status verified
May 2017
Primary completion
Sep 8, 2017
Completion
Sep 8, 2017

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Bendamustin, Rituximab, Temsirolimus

Primary Outcome Measure

Phase I: MTD / Phase II: ORR [ Time Frame: Phase I: 2 months (start cycle 3), Phase II: 6 months ]

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