MedTrace Logo

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

NCT00709592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-11-09

Study results available
· View outcomes & findings →

Summary

One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.

Conditions

Interventions

BIOLOGICAL

Thymoglobulin

Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Allogeneic PBSCT or BMT

Undergo allogeneic PBSCT or BMT

DRUG

Tacrolimus

Given PO

DRUG

Mycophenolate Mofetil

Given PO

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Amir Toor, MD · Massey Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-21
Primary Completion
2014-02-15
Completion
2017-06-28
FDA Drug
Yes

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 NCT00709592 on ClinicalTrials.gov