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Leukemia. 2016 Feb;30(2):261-7. doi: 10.1038/leu.2015.226. Epub 2015 Aug 18.

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

Author information

1
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany.
2
Medizinische Klinik III, Klinikum Chemnitz, Chemnitz, Germany.
3
Rems-Murr-Klinikum Winnenden, Winnenden, Germany.
4
Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe Universität Frankfurt am Main, Frankfurt, Germany.
5
Zentrum für Blutstammzell- und Knochenmarktransplantation, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.
6
5. Medizinische Klinik, Städtisches Klinikum Nord, Nürnberg, Germany.
7
Medizinische Klinik 5, Universitätsklinikum Erlangen, Erlangen, Germany.
8
III. Medizinische Klinik, Universitätsklinikum Mannheim, Mannheim, Germany.
9
Abteilung für Hämatologie, Onkologie, Immunologie, Rheumatologie und Pulmologie, Medizinische Universitätsklinik Tübingen, Tübingen, Germany.
10
Klinik für Hämatologie, Onkologie und Palliativmedizin, HELIOS Klinikum Bad Saarow, Bad Saarow, Germany.
11
Klinikapotheke, Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany.
12
German Cancer Consortium (DKTK), Heidelberg, Germany.
13
German Cancer Research Center (DKFZ), Heidelberg, Germany.
14
DKMS, German Bone Marrow Donor Center, Tübingen, Germany.

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.

PMID:
26283567
DOI:
10.1038/leu.2015.226
[Indexed for MEDLINE]

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