Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

Phase 2 Completed 32 enrolled Medical College of Wisconsin Blood and Marrow Transplant Clinical Trials Network · collab National Cancer Institute (NCI) · collab National Heart, Lung, and Blood Institute (NHLBI) · collab National Marrow Donor Program · collab

NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, multicenter phase II study with patients receiving haploidentical transplantation for Severe Aplastic Anemia (SAA). The primary objective is to assess overall survival (OS) at 1 year post-hematopoietic stem cell transplantation (HSCT).

Timeline

Start: 2017-07-03
Primary completion: 2021-08-17
Completion: 2021-08-17

Publications

Results DeZern AE, Eapen M, Wu J, Talano JA, Solh M, Davila Saldana BJ, Karanes C, Horwitz ME, Mallhi K, Arai S, Farhadfar N, Hexner E, Westervelt P, Antin JH, Deeg HJ, Leifer E, Brodsky RA, Logan BR, Horowitz MM, Jones RJ, Pulsipher MA. Haploidentical bone marrow transplantation in patients with relapsed or refractory severe aplastic anaemia in the USA (BMT CTN 1502): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2022 Sep;9(9):e660-e669. doi: 10.1016/S2352-3026(22)00206-X. Epub 2022 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE)	Protein / enzyme biologic	0.5 mg/kg	Intravenous
Background	ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE)	Protein / enzyme biologic	2 mg/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	14.5 mg/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	50 mg/kg	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	Mycophenolate Mofetil	Small molecule	15 mg/kg	Oral
Background	Tacrolimus	Small molecule	—	Oral
Background	filgrastim	Protein / enzyme biologic	5 ug/kg	Intravenous

Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

Summary

Timeline

Publications

Drugs

Indications