Open AccessProgressive substitution of posttransplant cyclophosphamide with bendamustine: A phase I study in haploidentical bone marrow transplantation
Author(s) -
Katsanis Emmanuel,
Maher Keri,
Roe Denise J.,
Simpson Richard J.
Publication year - 2020
Publication title -
ejhaem
Language(s) - English
Resource type - Journals
ISSN - 2688-6146
DOI - 10.1002/jha2.20
Subject(s) - bendamustine , cyclophosphamide , medicine , bone marrow , transplantation , phases of clinical research , gastroenterology , oncology , chemotherapy , lymphoma , rituximab
We have initiated a single center phase I study in patients with hematologic malignancies progressively substituting day +4 posttransplant cyclophosphamide (PT‐CY) with bendamustine (PT‐BEN) following myeloablative conditioning (MAC) and T‐cell replete haploidentical bone marrow transplantation (haplo‐BMT). We report herein our interim analysis of our first three cohorts PT‐CY (mg/kg)/PT‐BEN (mg/m 2 ): 40/20, 20/60, and 0/90. All patients have tolerated PT‐CY/BEN well with no dose limiting toxicities. Compared to contemporaneous controls undergoing haplo‐BMT with the same MAC regimens but only PT‐CY, we have observed earlier trilineage engraftment ( P = .002 neutrophils, P = .014 platelets) and a lower incidence of cytomegalovirus reactivation ( P = .016) in the PT‐CY/BEN cohorts. After substituting day +4 PT‐CY with PT‐BEN, the registered trial ( www.clinicaltrials.gov; NCT02996773 ) is proceeding to replace day +3 PT‐CY with PT‐BEN with a view to identifying further evidence on the potential advantages of PT‐BEN.