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

University of Nebraska

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lymphoma

Treatments: Drug: BEAM; Procedure: Autologous stem cell transplant; Drug: Rituxan

Study type: Interventional

Funder types: Other

Identifiers

NCT00572013

0138-98-FB

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Arm I Rituxan and BEAM post-autologous stem cell transplant

Experimental group

Description:

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.

Treatment:

Procedure: Autologous stem cell transplant

Drug: BEAM

Drug: Rituxan