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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00572013

Enrollment

Registered

2007-12-12

Start date

1998-05-12

Completion date

2009-09-18

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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.

Interventions

DRUGRituxan

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

DRUGBEAM

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

PROCEDUREAutologous stem cell transplant

following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Response rate	100 day	Disease response at day 100

Secondary

Measure	Time frame	Description
Overall survival	diagnosis until death	Survival time from diagnosis until death

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026