The addition of sirolimus to tacrolimus/methotrexate GVHD prophylaxis in children with ALL: a phase 3 Children’s Oncology Group/Pediatric Blood and Marrow Transplant Consortium trial

Author:

Pulsipher Michael A.1,Langholz Bryan2,Wall Donna A.3,Schultz Kirk R.4,Bunin Nancy5,Carroll William L.6,Raetz Elizabeth6,Gardner Sharon7,Gastier-Foster Julie M.8,Howrie Denise9,Goyal Rakesh K.10,Douglas James G.11,Borowitz Michael12,Barnes Yvonne13,Teachey David T.5,Taylor Candace14,Grupp Stephan A.5

Affiliation:

1. Division of Hematology and Hematological Malignancies, Huntsman Cancer Institute/University of Utah School of Medicine, Primary Children’s Hospital, Salt Lake City, UT;

2. Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA;

3. Manitoba Blood and Marrow Transplant Program, Winnepeg, MB, Canada;

4. Department of Pediatrics, University of British Columbia, British Columbia Children’s Hospital, Vancouver, BC, Canada;

5. Division of Oncology and Department of Pathology, Children’s Hospital of Philadelphia, and Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

6. Division of Pediatric Hematology/Oncology, Primary Children's Hospital, Huntsman Cancer Institute/University of Utah School of Medicine, Salt Lake City, UT;

7. New York University Department of Pediatrics and Cancer Institute, New York University Langone Medical Center, New York, NY;

8. Department of Pathology and Laboratory Medicine, Nationwide Children’s Hospital, and Departments of Pathology and Pediatrics, The Ohio State University College of Medicine, Columbus, OH;

9. Division of Hematology/Oncology and

10. Division of Blood and Marrow Transplantation and Cellular Therapies, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA;

11. Radiation Oncology, University of Washington Cancer Center, Seattle, WA;

12. Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD;

13. Hematology/Oncology, Washington University Medical Center, St. Louis, MO; and

14. Methodist Children’s Hospital of South Texas, San Antonio, TX

Abstract

Key Points Adding sirolimus to tacrolimus/methotrexate GVHD prophylaxis decreased grade 2-4 aGVHD but did not improve survival in pediatric ALL. The addition of sirolimus to tacrolimus/methotrexate increased rates of VOD and TMA compared with tacrolimus/methotrexate alone.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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