Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study|
- Optimal Bendamustine Dosage for Further Studies [ Time Frame: Three weeks after treatment termination ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Bendamustine and Bortezomib
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
Other Name: Ribomustin, SDX-105Drug: Bortezomib
weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
Other Name: Velcade
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426855
|Principal Investigator:||Peter R Moosmann, MD PhD||Cantonal Hospital of Aarau, Switzerland|