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Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies

NCT00472056 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2016-03-15

Study results available
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Summary

Cohort 1: Patients who are less than or equal to 65 years of age.

1\. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)

Cohort 2: Patients who are older than 65 years of age

1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
2. To determine the treatment related mortality (TRM)

Conditions

Interventions

DRUG

Carmustine

300 mg/m\^2 IV for 1 Day

DRUG

Etoposide

Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days

DRUG

Cytarabine

Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days

DRUG

Melphalan

140 mg/m\^2 IV x 1 Day

DRUG

Rituximab

Cohort 1, High-Dose Rituximab = 1000 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Chitra M. Hosing, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00472056 on ClinicalTrials.gov