Actively Recruiting

Phase 2
Age: 1Year - 75Years
All Genders
NCT02828592

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

Led by Northside Hospital, Inc. · Updated on 2026-04-20

20

Participants Needed

2

Research Sites

624 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Availability of a 3/6 to 5/6 matched related donor with negative HLA cross-match in the host vs. graft direction
  • Age 1 to 65 years for previously treated patients and up to 75 years for others
  • Karnofsky Performance Status (KPS) of 70% or higher
  • Diagnosis of severe aplastic anemia meeting at least two of the following peripheral blood criteria: neutrophils less than 500/mm3, platelets less than 20,000, or absolute reticulocyte count less than 40,000/microL
  • Bone marrow must be either markedly hypocellular (less than 25% normal cellularity) or moderately hypocellular with 70% non-myeloid precursors and meeting the peripheral blood criteria above
Not Eligible

You will not qualify if you...

  • Poor heart function with left ventricular ejection fraction less than 40%
  • Poor lung function with FEV1 and FVC less than 50% predicted
  • Poor liver function with bilirubin 2 mg/dL or higher
  • Poor kidney function with creatinine 2.0 mg/dL or higher or creatinine clearance less than 40 mL/min
  • Previous allogeneic transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States, 30342

Actively Recruiting

2

Northside Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

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Research Team

M

Melhem Solh, MD

CONTACT

S

Stacey Brown

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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