A multicenter, open, noncomparative, phase II study of the combination of cladribine (2-chlorodeoxyadenosine), cytarabine, granulocyte colony-stimulating factor and mitoxantrone as induction therapy in refractory acute myeloid leukemia: a report of the Polish Adult Leukemia Group.
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| Abstract |
Purine nucleoside analogues, cladribine (2-chlorodeoxyadenosine, 2-CdA) and fludarabine (FAMP) are active agents in acute myeloid leukemias (AMLs). Synergistic interaction between FAMP or 2-CdA with cytarabine (cytosine arabinoside, Ara-C) has been demonstrated in preclinical and clinical studies. The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of induction treatment consisting of 2-CdA (5 mg/m2), Ara-C (2 g/m2), mitoxantrone (MIT, 10 mg/m2) and granulocyte colony-stimulating factor (G-CSF) (CLAG-M) in refractory AML. In case of partial remission, a second CLAG-M was administered. Patients in complete remission (CR) received consolidation courses based on high-dose Ara-C and MIT with or without 2-CdA. Forty-three patients from five centers were registered: 25 primary resistant and 18 relapsed. CR was achieved in 21 (49%) patients, 20 (47%) were refractory and 2 (5%) died early. Hematologic toxicity was the most prominent toxicity of this regimen. The overall survival (OS; 1 year) for the 42 patients as a whole and the 20 patients in CR were 43% and 73%, respectively. Disease-free survival (1 year) was 68.6%. None of the analyzed prognostic factors influenced the CR and OS probability significantly. We conclude that CLAG-M regimen has significant antileukemia activity in refractory AML, which seems to be better than the activity of many other regimens. The toxicity of the treatment is acceptable.
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| Authors | A Wrzesień-Kuś, T Robak, A Wierzbowska, E Lech-Marańda, A Pluta, E Wawrzyniak, A Krawczyńska, K Kuliczkowski, G Mazur, M Kiebiński, A Dmoszyńska, M Wach, A Hellmann, W Baran, J Hołowiecki, S Kyrcz-Krzemień, S Grosicki, Polish Adult Leukemia Group |
| Journal | Annals of hematology (Ann Hematol) Vol. 84 Issue 9 Pg. 557-64 (Sep 2005) ISSN: 0939-5555 [Print] Germany |
| PMID | 15856358 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study) |
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