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Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia

NCT00427791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-05-09

Study results available
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Summary

Primary Objective:

* To determine the progression free survival (PFS) of the preparative regimen rituximab, etoposide and total body irradiation (TBI), in patients with acute lymphoblastic leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT).

Secondary Objectives:

* To determine the effect of rituximab on the incidence of acute graft vs. host disease (GVHD).
* To determine the efficacy of adding imatinib mesylate post transplant in ALL patients with the t(9;22)(q34;q11) cytogenetic abnormality.
* To estimate the probability of molecular complete remission at one year for the described treatment approach as determined by serial minimal residual disease (MRD) monitoring.
* To determine the rate of GVHD, engraftment, toxicity, and overall survival (OS) for this treatment regimen.

Conditions

Interventions

DRUG

Etoposide

60 mg/kg IV Daily Over 4 Hours for 1 Day

RADIATION

Total Body Irradiation

3 Gy Daily for 4 Days

DRUG

Rituximab

375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Partow Kebriaei, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-10-31
Completion
2009-10-31

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 NCT00427791 on ClinicalTrials.gov