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

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

Detailed Description
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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.

Official Title
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A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Rituxan
* Drug: BEAM
* Procedure: Autologous stem cell transplant


Participation Criteria
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Eligibility Criteria
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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). o 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 WHO performance status greater or equal to 2 Male or female subjects of reproductive potential who are able to follow accepted birth control measures. Exclusion Criteria: No history of T-cell lymphoma Not pregnant or lactating women No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I Rituxan and BEAM post-autologous stem cell transplant<br>Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant. | Drug: Rituxan<br>* 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<br>* Other names: Rituximab;Drug: BEAM<br>* 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<br>Procedure: Autologous stem cell transplant<br>* following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Disease response at day 100 | 100 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival time from diagnosis until death | diagnosis until death |