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Bone Marrow Transplant From Donor Using Less Toxic Conditioning for Patient With High Risk Hemoglobinopathies

NCT00040417 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-18

No results posted yet for this study

Summary

The major goal of this study is to determine the risks and benefits of stem cell transplants in combination with a newer, less toxic conditioning chemotherapy treatment in patients with severe sickle cell disease (SCD) or sickle hemoglobin variants (hemoglobin SC or hemoglobin SB0/+), or homozygous b0/+ thalassemia or severe B0/+ thalassemia variants. Participation in this project will be for one year, with follow up evaluations done every 6 months thereafter for 10 years or until participants are 18 years old.

Conditions

Interventions

DRUG

FLUDARABINE

DRUG

CAMPATH-IH

PROCEDURE

Total Body Irradiation

DRUG

FK506

DRUG

G-SCF (Granulocyte-colony stimulating factor)

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Malcolm K. Brenner, MD, FRCP · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2003-11-21
Completion
2003-11-21

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 NCT00040417 on ClinicalTrials.gov