MedTrace Logo

Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies

NCT00153985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-07-30

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.

Conditions

Interventions

DRUG

Busulfex

Given once daily for 4 days

DRUG

Fludarabine

Given intravenously once daily for 4 days

DRUG

Alemtuzumab

One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days.

PROCEDURE

Stem Cell Transfusion

Performed three days after the end of chemotherapy

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Catherine J. Wu, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-03-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00153985 on ClinicalTrials.gov