Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

Phase 2 Completed 43 enrolled Dimitrios Tzachanis, MD PhD Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.

Timeline

Start: 2019-11-26
Primary completion: 2023-06-15
Completion: 2023-06-15

Outcome

Met primary endpoint

paper The trial met its primary end point: PMID 40554429 ↗

paper were 0% on the PTCy+Aba and 65.8% on the SOC arm (P < .0001). PMID 40554429 ↗

Publications

Koura D, Dykes K, Goodman A, Costello C, Mulroney C, Mangan JK, Tanaka TN, Ball ED, Hamdan A, Jeong AR, Mirocha J, Zhang Q, Ogrodnik P, McConnell K, Maroge JJ, Padilla M, Morris GP, Tzachanis D. A prospective clinical trial of GVHD prophylaxis with posttransplant cyclophosphamide and abatacept. Blood Adv. 2025 Aug 26;9(16):4336-4344. doi: 10.1182/bloodadvances.2024015094.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	10 mg/kg	—
Subject	Cyclophosphamide	Other / unclassified	—	—
Comparator	Methotrexate	Small molecule	5 mg/m2	—
Comparator	Tacrolimus	Small molecule	—	—