Haploidentical bone marrow transplant for severe aplastic anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of haploidentical bone marrow transplantation in patients with severe aplastic anemia who lack suitable HLA-matched donors. Participants will undergo a preparative regimen involving Fludarabine, Cyclophosphamide, and Total Body Irradiation, followed by transplantation from a mismatched donor. Post-transplant, Cyclophosphamide will be administered to reduce the risk of graft failure. The study will assess the graft failure rate and overall patient outcomes to determine the viability of this approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor who must have negative HLA cross-match in the host vs. graft direction
* Age \<= 65 years for previously treated and \<= 75 years for previously treated patients
* KPS \>= 70%
* Aplastic Anemia that meets the following criteria:

Peripheral Blood (must fulfill 2 of 3):

* \<500 PMN/mm3
* \<20,000 platelets
* absolute reticulocyte count \<40,000/microL

Bone Marrow (must be either):

* markedly hypocellular (\<25% of normal cellularity)
* moderately hypocellular with 70% non-myeloid precursors and patient meets peripheral blood criteria above

Exclusion Criteria:

* poor cardiac function (LVEF \<40%)
* poor pulmonary function (FEV1 \& FVC \<50% predicted)
* poor liver function (bili \>= 2mg/dL)
* poor renal function (creatinine \>= 2.0mg/dL or creatinine clearance \<40mL/min)
* prior allogeneic transplant

Where it's running

• Blood and Marrow Transplant Group of Georgia
  Atlanta, Georgia, United States Recruiting
• Northside Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Melhem Solh, MD — Blood and Marrow Transplant Group of Georgia
• Study coordinator: Melhem Solh, MD
• Email: msolh@bmtga.com
• Phone: 404-255-1930

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.