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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426855
First Posted: January 25, 2007
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kantonsspital Aarau
Information provided by (Responsible Party):
Peter Moosmann, Kantonsspital Aarau
  Purpose
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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin Drug: Bendamustine Drug: Bortezomib Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Peter Moosmann, Kantonsspital Aarau:

Primary Outcome Measures:
  • Optimal Bendamustine Dosage for Further Studies [ Time Frame: Three weeks after treatment termination ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine and Bortezomib
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
Drug: Bendamustine
starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
Other Name: Ribomustin, SDX-105
Drug: Bortezomib
weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
Other Name: Velcade

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426855


Sponsors and Collaborators
Peter Moosmann
Kantonsspital Aarau
Investigators
Principal Investigator: Peter R Moosmann, MD PhD Cantonal Hospital of Aarau, Switzerland
  More Information

Publications:
Responsible Party: Peter Moosmann, MD PhD, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT00426855     History of Changes
Other Study ID Numbers: ZOHT-01/07
First Submitted: January 24, 2007
First Posted: January 25, 2007
Results First Submitted: June 27, 2011
Results First Posted: April 3, 2015
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Peter Moosmann, Kantonsspital Aarau:
Lymphoma, Non-Hodgkin, Low-Grade

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Bendamustine Hydrochloride
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action