Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

NCT ID: NCT00426855

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bendamustine and Bortezomib

Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w

Bortezomib

Intervention Type: DRUG

weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w

Interventions

Bendamustine

starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w

Intervention Type: DRUG

Bortezomib

weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w

Intervention Type: DRUG

Other Intervention Names

Ribomustin, SDX-105; Velcade

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Aarau

OTHER

Sponsor Role: collaborator

Peter Moosmann

OTHER

Sponsor Role: lead

Responsible Party

Peter Moosmann

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter R Moosmann, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital of Aarau, Switzerland

References

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.

Reference Type: RESULT

PMID: 19860608 (View on PubMed)

Other Identifiers

ZOHT-01/07

Identifier Type: -

Identifier Source: org_study_id