Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bendamustine
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Non-Hodgkin, Low-Grade
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bendamustine and Bortezomib
Arm Description
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
Outcomes
Primary Outcome Measures
Optimal Bendamustine Dosage for Further Studies
Secondary Outcome Measures
Full Information
NCT ID
NCT00426855
First Posted
January 24, 2007
Last Updated
April 2, 2015
Sponsor
Peter Moosmann
Collaborators
Kantonsspital Aarau
1. Study Identification
Unique Protocol Identification Number
NCT00426855
Brief Title
Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Moosmann
Collaborators
Kantonsspital Aarau
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Lymphoma, Non-Hodgkin, Low-Grade
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bendamustine and Bortezomib
Arm Type
Experimental
Arm Description
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Ribomustin, SDX-105
Intervention Description
starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
Primary Outcome Measure Information:
Title
Optimal Bendamustine Dosage for Further Studies
Time Frame
Three weeks after treatment termination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R Moosmann, MD PhD
Organizational Affiliation
Cantonal Hospital of Aarau, Switzerland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19860608
Citation
Moosmann P, Heizmann M, Kotrubczik N, Wernli M, Bargetzi M. Weekly treatment with a combination of bortezomib and bendamustine in relapsed or refractory indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2010 Jan;51(1):149-52. doi: 10.3109/10428190903275602. No abstract available.
Results Reference
result
Learn more about this trial
Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
We'll reach out to this number within 24 hrs