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NCORP Trials

Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)

Status
Closed
Cancer Type
Unknown Primary
Trial Phase
Phase II
Eligibility
5 - 45 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03263559
Protocol IDs
BMTCTN1507 (primary)
NCI-2018-02407
5U24CA076518
2U10HL069294-11
Study Sponsor
Medical College of Wisconsin
NCI Full Details
http://clinicaltrials.gov/show/NCT03263559

Summary

This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and
toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell
disease (SCD). Based on their age and entry criteria patients are stratified into two groups:
(1) children with severe SCD; and (2) adults with severe SCD.

Objectives

This study is designed as a Phase II multi-center trial to determine the feasibility of
achieving a high rate of event-free survival (EFS) at 2 years post transplant using
pre-conditioning hydroxyurea (HU) with a conditioning regimen that consists of a combination
of Thymoglobulin/Cyclophosphamide/Fludarabine/Thiotepa with post-grafting high-dose
cyclophosphamide in patients with severe SCD who have HLA-haploidentical donors. EFS is
defined as survival without a qualifying event. This is a single arm study in which
participants will be enrolled into one of two strata. The first stratum will be restricted to
children who have stroke and 40 children will be enrolled in this stratum. The second stratum
will consist of adult patients with severe sickle cell disease and 40 participants will be
enrolled in this stratum.

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
Melhem Solh MD
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