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RECRUITING
NCT02828592
PHASE2

Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia

Sponsor: Northside Hospital, Inc.

View on ClinicalTrials.gov

Summary

Severe aplastic anemia is a rare and serious form of bone marrow failure related to an immune-mediated mechanism that results in severe pancytopenia and high risk for infections and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance of survival; however, a response rate with just immunosuppression for those patients lacking suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3 relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical donor for transplantation has good response rates and significantly lower rates of acute and chronic GVHD.

Official title: A Study of T-Cell Replete, HLA-Mismatched Haploidentical Bone Marrow Transplantation With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related Donor

Key Details

Gender

All

Age Range

1 Year - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2016-09-09

Completion Date

2027-08-31

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DRUG

Fludarabine

30 mg/m2 IV QD x 5 days (Days -6 to -2)

DRUG

Cyclophosphamide

14.5 mg/kg/day IV x 2 doses (Days -6 \& -5)

RADIATION

Total Body Irradiation

300 cGy x1 dose (Day -1)

DRUG

Rabbit ATG

1.5 mg/kg/day x 3 days (Days -3 to -1)

DRUG

Cyclophosphamide

Post-transplant: 50 mg/kg IV QD (Day +3 to +4)

Locations (2)

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States