- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00426855
Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Optimal Bendamustine Dosage for Further Studies
Time Frame: Three weeks after treatment termination
|
Three weeks after treatment termination
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter R Moosmann, MD PhD, Cantonal Hospital of Aarau, Switzerland
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Bendamustine Hydrochloride
- Bortezomib
Other Study ID Numbers
- ZOHT-01/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRefractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Hematopoietic Cell Transplantation RecipientUnited States
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Acerta Pharma BVAstraZenecaActive, not recruitingNon Hodgkin LymphomaUnited States, Canada, Italy
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