Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study
18 Years
N/A
Both
Lymphoma, Non-Hodgkin
Trial Information
Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study
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.
Inclusion Criteria:
- Symptomatic recurrent or refractory indolent NHL or B-CLL
- Adequate organ and bone marrow function
- Karnofsky greater than 50%
Exclusion Criteria:
- Candidates for autologous stem cell transplantation
- Secondary high grade lymphoma
- Concurrent severe medical condition
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Optimal dosage
Outcome Time Frame:
Treatment period
Safety Issue:
Yes
Principal Investigator
Peter R Moosmann, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cantonal Hospital of Aarau
Authority:
Switzerland: Swissmedic
Study ID:
ZOHT-01/07
NCT ID:
NCT00426855
Start Date:
January 2007
Completion Date:
June 2009
Related Keywords:
- Lymphoma, Non-Hodgkin
- Lymphoma, Non-Hodgkin, Low-Grade
- Lymphoma
- Lymphoma, Non-Hodgkin
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