drugset / Trial / NCT01012492
Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.
Timeline
- Start
- 2009-11
- Primary completion
- 2012-11
- Completion
- 2013-01
Publications
- Results Koura DT, Horan JT, Langston AA, Qayed M, Mehta A, Khoury HJ, Harvey RD, Suessmuth Y, Couture C, Carr J, Grizzle A, Johnson HR, Cheeseman JA, Conger JA, Robertson J, Stempora L, Johnson BE, Garrett A, Kirk AD, Larsen CP, Waller EK, Kean LS. In vivo T cell costimulation blockade with abatacept for acute graft-versus-host disease prevention: a first-in-disease trial. Biol Blood Marrow Transplant. 2013 Nov;19(11):1638-49. doi: 10.1016/j.bbmt.2013.09.003. Epub 2013 Sep 15.
- Results Suessmuth Y, Mukherjee R, Watkins B, Koura DT, Finstermeier K, Desmarais C, Stempora L, Horan JT, Langston A, Qayed M, Khoury HJ, Grizzle A, Cheeseman JA, Conger JA, Robertson J, Garrett A, Kirk AD, Waller EK, Blazar BR, Mehta AK, Robins HS, Kean LS. CMV reactivation drives posttransplant T-cell reconstitution and results in defects in the underlying TCRbeta repertoire. Blood. 2015 Jun 18;125(25):3835-50. doi: 10.1182/blood-2015-03-631853. Epub 2015 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 10 mg/kg | — |
Indications
acute biphenotypic leukemia
acute undifferentiated leukemia
myelodysplastic syndrome associated with isolated del(5q)
myelodysplastic syndrome with excess blasts-1
myelodysplastic syndrome with excess blasts-2
myelodysplastic syndrome with multilineage dysplasia
myelodysplastic syndrome with ring sideroblasts