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Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies

NCT00476229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-08-07

Study results available
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Summary

Primary Objective:

1\. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%.

Secondary Objectives:

1. To determine the cumulative incidence of chronic graft versus host disease.
2. To determine the overall and disease free survival.

Conditions

Interventions

DRUG

Thymoglobulin

1.5 mg/kg by vein on Days -11 to -7.

RADIATION

Total Lymphoid Irradiation

80 cGy daily on days -11 to -7 and -4 to 0.

PROCEDURE

Peripheral Blood Stem Cell Infusion

PBSC infusion administered on day 0.

DRUG

Rituximab

375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-05-31
Completion
2009-05-31

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 NCT00476229 on ClinicalTrials.gov