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Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation

NCT00591630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-02

Study results available
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Summary

The goal of this clinical research study is to learn if the addition of 90Y Zevalin to BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more effective than the combination of BEAM and rituximab alone in patients with lymphoma who receive a stem cell transplant.

Conditions

Interventions

DRUG

Zevalin

(111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.

DRUG

Carmustine

300 mg/m\^2 by vein.

DRUG

Etoposide

200 mg/m\^2 by vein every 12 hours.

DRUG

Cytarabine

200 mg/m\^2 by vein every 12 hours.

DRUG

Melphalan

140 mg/m\^2 by vein.

DRUG

Rituximab

Arm 1, Arm 2 = 250 mg/m\^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.

PROCEDURE

Stem Cell Transplant

Injection of stem cells (Autologous SCT)

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa F. Khouri, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-14
Primary Completion
2020-03-05
Completion
2020-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00591630 on ClinicalTrials.gov