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OCTET ‐ CY : a phase II study to investigate the efficacy of post‐transplant cyclophosphamide as sole graft‐versus‐host prophylaxis after allogeneic peripheral blood stem cell transplantation
Author(s) -
Holtick Udo,
Chemnitz JensMarkus,
ShimabukuroVornhagen Alexander,
Theurich Sebastian,
Chakupurakal Geothy,
Krause Anke,
Fiedler Anne,
Luznik Leo,
Hellmich Martin,
Wolf Dominik,
Hallek Michael,
BergweltBaildon Michael,
Scheid Christof
Publication year - 2016
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12541
Subject(s) - cyclophosphamide , medicine , fludarabine , busulfan , immunosuppression , transplantation , immunology , gastroenterology , surgery , chemotherapy
Abstract Objective Post‐transplant cyclophosphamide is increasingly used as graft‐versus‐host disease (Gv HD ) prophylaxis in the setting of bone marrow transplantation. No data have been published on the use of single‐agent Gv HD prophylaxis with post‐transplant cyclophosphamide in the setting of peripheral blood stem cell transplantation ( PBSCT ). Methods In a phase II trial, 11 patients with myeloma or lymphoma underwent conditioning with fludarabine and busulfan followed by T‐replete PBSCT and application of 50 mg/kg/d of cyclophosphamide on day+3 and +4 without other concurrent immunosuppression (IS). Results Median time to leukocyte, neutrophil, and platelet engraftment was 18, 21, and 18 d. The incidence of grade II – IV and grade III – IV Gv HD was 45% and 27%, with a non‐relapse mortality (NRM) of 36% at one and 2 yr. After median follow‐up of 927 d, overall and relapse‐free survival was 64% and 34%. Three patients did not require any further systemic IS until day+100 and thereafter. Analysis of immune reconstitution demonstrated rapid T‐ and NK ‐cell recovery. B‐ and CD 3+/ CD 161+ NK /T‐cell recovery was superior in patients not receiving additional IS. Conclusion Post‐transplant cyclophosphamide as sole IS in PBSCT is feasible and allows rapid immune recovery. Increased rates of severe acute Gv HD explain the observed NRM and may advise a temporary combination partner such as mT or‐inhibitors in the PBSCT setting.