A Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic Anemia

NCT02833805 Phase 2 COMPLETED Results posted

Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.

Details

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	COMPLETED
Enrolment	21
Start date	2016-09
Completion	2021-07

Conditions

• Severe Aplastic Anemia
• Aplastic Anemia
• Bone Marrow Failure
• Immunosuppression

Interventions

• Thymoglobulin
• Fludarabine
• Cyclophosphamide
• Total body irradiation
• Tacrolimus
• Mycophenolate mofetil

Primary outcomes

• Overall Survival and Engraftment at One Year — 1 year
  Number of enrolled participants who receive BMT, achieve engraftment, and are alive at one year post bone marrow transplant (BMT).

Countries

United States