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

This study has been completed.
Sponsor:
Information provided by:
Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00426855
First received: January 24, 2007
Last updated: November 5, 2009
Last verified: November 2009
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Optimal dosage [ Time Frame: Treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Treatment period ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: one year ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: Bendamustine
    starting with 60 mg/m2, dose escalation, weekly d1,8,15 q5w
    Drug: Bortezomib
    weekly 1.5mg/m2, d1,8,15,22 q5w
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426855

Sponsors and Collaborators
Kantonsspital Aarau
Investigators
Principal Investigator: Peter R Moosmann, MD PhD Cantonal Hospital of Aarau
  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, 26866138LYM1003
Study First Received: January 24, 2007
Last Updated: November 5, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by 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
 Bendamustine
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013