The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.
Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.
Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression.
Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
Berlin, State of Berlin, Germany
Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
Berlin, State of Berlin, Germany
Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité
Berlin, State of Berlin, Germany
Phase I: Dose-finding
Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.
Time frame: 6 months
Phase II: Response Rate (Overall response rate, complete and partial response)
What is the response rate of a therapy with temsirolimus and bendamustine.
Time frame: 6 months
Progression free survival
This is defined as the period of time between the admission into the clinical trial and the progression of the lymphoma or death of any kind.
Time frame: 2 years
Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy
Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
Time frame: 2 years
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