Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm I
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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:
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
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Outcome Measures
Primary Outcome Measures
- response rate [100 day]
Secondary Outcome Measures
- overall survival [diagnosis until death]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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At least 19 years of age
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Signed written informed consent
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Expected survival of at least 6 months
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Subjects with out history of T-cell lymphoma
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WHO performance status greater or equal to 2
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Subjects without serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
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Non-pregnant and non-lactating women
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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.- 138-98
- IRB#138-98