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



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:1/19/2018
Start Date:May 1998
End Date:September 2009

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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

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

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.

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.
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