Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

Sponsor
University of Nebraska (Other)
Overall Status
Completed
CT.gov ID
NCT00572013
Collaborator
(none)
32
1
1
136
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Study Details

Study Description

Brief Summary

To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.

This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Study Start Date :
May 1, 1998
Actual Primary Completion Date :
Jan 1, 2001
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Drug: Rituxan
375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
Other Names:
  • Rituximab
  • Drug: BEAM
    BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1

    Procedure: Autologous stem cell transplant
    following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

    Outcome Measures

    Primary Outcome Measures

    1. response rate [100 day]

    Secondary Outcome Measures

    1. overall survival [diagnosis until death]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR). Specifically: Small lymphocytic, marginal zone, mantle cell, and follicular histologies.

    • At least 19 years of age

    • Signed written informed consent

    • Expected survival of at least 6 months

    • Subjects with out history of T-cell lymphoma

    • WHO performance status greater or equal to 2

    • Subjects without serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.

    • Non-pregnant and non-lactating women

    • Male or female subjects of reproductive potential who are able to follow accepted birth control measures.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Nebraska Medical Center, Section of Oncology/Hematology Omaha Nebraska United States 68198

    Sponsors and Collaborators

    • University of Nebraska

    Investigators

    • Principal Investigator: Julie M Vose, M.D., University of Nebraska

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie M Vose, MD, Principal Investigator, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT00572013
    Other Study ID Numbers:
    • 138-98
    • IRB#138-98
    First Posted:
    Dec 12, 2007
    Last Update Posted:
    Jan 17, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 17, 2018