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Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome

NCT00475020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-05-21

Study results available
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Summary

The goal of this clinical research study is to learn if using a combination of fludarabine, busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant. The safety of these drugs will also be studied.

Conditions

Interventions

DRUG

Busulfan

Test dose = 32 mg/m\^2 by vein x 1 day; 100 mg/m\^2 by vein daily over 3 hours x 4 days

DRUG

Fludarabine

40 mg/m\^2 by vein daily over 1 hour x 4 days

DRUG

Thymoglobulin (ATG)

2.5 mg/kg by vein over 6 hours x 3 days if there is an unrelated or a mismatched donor

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Uday Popat, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-04
Primary Completion
2017-10-04
Completion
2017-10-04
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 NCT00475020 on ClinicalTrials.gov