Double unrelated umbilical cord blood vs HLA-haploidentical bone marrow transplantation: the BMT CTN 1101 trial

Author:

Fuchs Ephraim J.1ORCID,O’Donnell Paul V.2,Eapen Mary3,Logan Brent4,Antin Joseph H.5,Dawson Peter6,Devine Steven7,Horowitz Mary M.3,Horwitz Mitchell E.8,Karanes Chatchada9,Leifer Eric10,Magenau John M.11,McGuirk Joseph P.12ORCID,Morris Lawrence E.13,Rezvani Andrew R.14,Jones Richard J.1,Brunstein Claudio G.15ORCID

Affiliation:

1. Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD;

2. Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA;

3. Center for International Blood and Marrow Transplant Research, Department of Medicine, and

4. Division of Biostatistics, Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI;

5. Department of Hematologic Malignancies, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;

6. Emmes Corporation, Rockville, MD;

7. National Marrow Donor Program, Minneapolis, MN;

8. Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University Medical Center, Durham, NC;

9. Department of Hematology/Hematopoietic Cell Transplantation (HCT), City of Hope National Medical Center, Duarte, CA;

10. Office of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD;

11. Michigan Medicine Bone Marrow Transplant and Leukemia, C. S. Mott Children’s Hospital, University of Michigan, Ann Arbor, MI;

12. Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Kansas City, KS;

13. Blood and Marrow Transplant Program, Northside Hospital, Atlanta, GA;

14. Division of Blood and Marrow Transplantation, Department of Medicine, Stanford University Medical Center, Stanford, CA; and

15. Division of Hematology, Oncology, and Transplantation, University of Minnesota, Minneapolis, MN

Abstract

Abstract Results of 2 parallel phase 2 trials of transplantation of unrelated umbilical cord blood (UCB) or bone marrow (BM) from HLA-haploidentical relatives provided equipoise for direct comparison of these donor sources. Between June 2012 and June 2018, 368 patients aged 18 to 70 years with chemotherapy-sensitive lymphoma or acute leukemia in remission were randomly assigned to undergo UCB (n = 186) or haploidentical (n = 182) transplant. Reduced-intensity conditioning comprised total-body irradiation with cyclophosphamide and fludarabine for both donor types. Graft-versus-host disease prophylaxis for UCB transplantation was cyclosporine and mycophenolate mofetil (MMF) and for haploidentical transplantation, posttransplant cyclophosphamide, tacrolimus, and MMF. The primary end point was 2-year progression-free survival (PFS). Treatment groups had similar age, sex, self-reported ethnic origin, performance status, disease, and disease status at randomization. Two-year PFS was 35% (95% confidence interval [CI], 28% to 42%) compared with 41% (95% CI, 34% to 48%) after UCB and haploidentical transplants, respectively (P = .41). Prespecified analysis of secondary end points recorded higher 2-year nonrelapse mortality after UCB, 18% (95% CI, 13% to 24%), compared with haploidentical transplantation, 11% (95% CI, 6% to 16%), P = .04. This led to lower 2-year overall survival (OS) after UCB compared with haploidentical transplantation, 46% (95% CI, 38-53) and 57% (95% CI 49% to 64%), respectively (P = .04). The trial did not demonstrate a statistically significant difference in the primary end point, 2-year PFS, between the donor sources. Although both donor sources extend access to reduced-intensity transplantation, analyses of secondary end points, including OS, favor haploidentical BM donors. This trial was registered at www.clinicaltrials.gov as #NCT01597778.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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