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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
Peter Moosmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Non-Hodgkin, Low-Grade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 24, 2007
    Last Updated
    April 2, 2015
    Sponsor
    Peter Moosmann
    Collaborators
    Kantonsspital Aarau
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    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
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    Learn more about this trial

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

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