Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2016-02

AUTHORS

J M Middeke, R Herbst, S Parmentier, G Bug, M Hänel, G Stuhler, K Schäfer-Eckart, W Rösler, S Klein, W Bethge, U Bitz, B Büttner, H Knoth, N Alakel, M Schaich, A Morgner, M Kramer, K Sockel, M von Bonin, F Stölzel, U Platzbecker, C Röllig, C Thiede, G Ehninger, M Bornhäuser, J Schetelig

ABSTRACT

In patients with relapsed or refractory (r/r) acute myeloid leukemia (AML), long-term disease control can only be achieved by allogeneic hematopoietic stem cell transplantation (HSCT). We studied the safety and efficacy of clofarabine-based salvage therapy. The study was designed as phase II, multicenter, intent-to-transplant (ITT) study. A total of 84 patients with r/r AML were enrolled. All patients received at least one cycle of CLARA (clofarabine 30 mg/m(2) and cytarabine 1 g/m(2), days 1-5). Chemo-responsive patients with a donor received HSCT in aplasia after first CLARA. Generally, HSCT was performed as soon as possible. The conditioning regimen consisted of clofarabine (4 × 30 mg/m(2)) and melphalan (140 mg/m(2)). The median patient age was 61 years (range 40-75). On day 15 after start of CLARA, 26% of patients were in a morphologically leukemia-free state and 79% exposed a reduction in bone marrow blasts. Overall, 67% of the patients received HSCT within the trial. The primary end point, defined as complete remission after HSCT, was achieved by 60% of the patients. According to the ITT, overall survival at 2 years was 43% (95% confidence interval (CI), 32-54%). The 2-year disease-free survival for transplanted patients was 52% (95% CI, 40-69%). Clofarabine-based salvage therapy combined with allogeneic HSCT in aplasia shows promising results in patients with r/r AML. More... »

PAGES

261

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/leu.2015.226

DOI

http://dx.doi.org/10.1038/leu.2015.226

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1000261332

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26283567


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