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

Middeke JM, Herbst R, Parmentier S, Bug G, Haenel M, Stuhlers G, Schaefer-Eckart K, Rösler W, Klein S, Bethge W, Bitz U, Buettner B, Knoth H, Alakel N, Schaich M, Morgner A, Kramer M, Sockel K, Von Bonin M, Stoelzel F, Platzbecker U, Roellig C, Thiede C, Ehninger G, Bornhaeuser M, Schetelig J (2016)


Publication Type: Journal article

Publication year: 2016

Journal

Book Volume: 30

Pages Range: 261-267

Journal Issue: 2

DOI: 10.1038/leu.2015.226

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.

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APA:

Middeke, J.M., Herbst, R., Parmentier, S., Bug, G., Haenel, M., Stuhlers, G.,... Schetelig, J. (2016). Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE trial. Leukemia, 30(2), 261-267. https://dx.doi.org/10.1038/leu.2015.226

MLA:

Middeke, J. M., et al. "Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE trial." Leukemia 30.2 (2016): 261-267.

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