Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE trial
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, multic...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2016
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| In: |
Leukemia
Year: 2015, Volume: 30, Issue: 2, Pages: 261-267 |
| ISSN: | 1476-5551 |
| DOI: | 10.1038/leu.2015.226 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1038/leu.2015.226 Verlag, Volltext: https://www-nature-com.ezproxy.medma.uni-heidelberg.de/articles/leu2015226 
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| Author Notes: | 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 and J. Schetelig for the Study Alliance Leukemia (SAL) |
| Summary: | 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/m2 and cytarabine 1 g/m2, 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/m2) and melphalan (140 mg/m2). 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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| Item Description: | Gesehen am 04.02.2019 Advance online publication, 11 September 2015 |
| Physical Description: | Online Resource |
| ISSN: | 1476-5551 |
| DOI: | 10.1038/leu.2015.226 |