Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
|ClinicalTrials.gov Identifier: NCT01170052|
Recruitment Status : Withdrawn (insufficient enrollment)
First Posted : July 27, 2010
Last Update Posted : March 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Temsirolimus Drug: Bendamustine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||April 2014|
- Phase I: Dose-finding [ Time Frame: 6 months ]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.
- Phase II: Response Rate (Overall response rate, complete and partial response) [ Time Frame: 6 months ]What is the response rate of a therapy with temsirolimus and bendamustine.
- Progression free survival [ Time Frame: 2 years ]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.
- Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy [ Time Frame: 2 years ]Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170052
|Dept. of Hematology and Oncology, Charité, Campus Charité Mitte|
|Berlin, Germany, 10117|
|Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin|
|Berlin, Germany, 12203|
|Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité|
|Berlin, Germany, 13353|
|Principal Investigator:||Christian Scholz, PD Dr.||Charite University, Berlin, Germany|