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

Phase 1

Completed

• Conditions: Lymphoma
• Interventions: Drug: Rituxan; Drug: BEAM; Procedure: Autologous stem cell transplant

• Registration Number: NCT00572013
• Lead Sponsor: University of Nebraska

Brief Summary

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

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 Timeline

• Study Start: 1998-05-12
• Primary Completion: 2001-01-01
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Study Completion: 2009-09-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I Rituxan and BEAM post-autologous stem cell transplant	Autologous stem cell transplant	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.
Arm I Rituxan and BEAM post-autologous stem cell transplant	Rituxan	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.
Arm I Rituxan and BEAM post-autologous stem cell transplant	BEAM	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.

Primary Outcome Measures

Name	Time	Method
Response rate	100 day	Disease response at day 100

Secondary Outcome Measures

Name	Time	Method
Overall survival	diagnosis until death	Survival time from diagnosis until death

Trial Locations

Locations (1)

University of Nebraska Medical Center, Section of Oncology/Hematology; 🇺🇸 Omaha, Nebraska, United States