Background: Clofarabine, a second-generation purine analog, is highly active as a single agent in AML and has synergistic activities with cytosine arabinoside (Ara-C). We herein report the results of the combined phase I and II parts of the EORTC/GIMEMA AML-14A study. Methods: Patients aged 18-60 years with previously untreated intermediate/high-risk AML or high-risk MDS were randomized for remission induction chemotherapy (1 or 2 cycles) between 1-hr infusion (Arm A) or push injection (Arm B) of clofarabine administered at 10 mg/m2 on days 2, 4, 6, 8 and 10 in combination with Ara-C (100 mg/m2/day on days 1-10) and idarubicin (10 mg/m2/day, on days 1, 3, and 5). One cycle of consolidation including Ara-C and idarubicin was administered in patients who achieved a CR/CRi. Primary endpoint was the CR/CRi rate after 1 or 2 cycles. Results: Among the 62 eligible patients (31 in each randomized arm), 5 had high-risk MDS. Median age was 50 years (range 20-60). The CR/CRi rate after induction was 84% (26 of 31 patients) in each arm (95% CI: 66-95%). During the induction/consolidation phase, 4 toxic deaths occurred in Arm A and one in Arm B. However, documented fungal infections during the induction phase were more frequent in Arm B (29%) than in Arm A (13%). Conclusions: Both low dose clofarabine containing regimens yielded an impressive CR/CRi rate (84%) with acceptable toxicity among patients with intermediate/high-risk AML or high-risk MDS.

Selleslag, D., Suciu, S., Meloni, G., Muus, P., Halkes, C., Venditti, A., et al. (2017). Low dose clofarabine in combination with a standard remission induction in patients 18-60 years with previously untreated intermediate and bad risk AML or high risk MDS:combined Phase I/II results of the EORTC/GIMEMA AML-14A Trial. HAEMATOLOGICA [10.3324/haematol.2016.153130].

Low dose clofarabine in combination with a standard remission induction in patients 18-60 years with previously untreated intermediate and bad risk AML or high risk MDS:combined Phase I/II results of the EORTC/GIMEMA AML-14A Trial

VENDITTI, ADRIANO;AMADORI, SERGIO;
2017

Abstract

Background: Clofarabine, a second-generation purine analog, is highly active as a single agent in AML and has synergistic activities with cytosine arabinoside (Ara-C). We herein report the results of the combined phase I and II parts of the EORTC/GIMEMA AML-14A study. Methods: Patients aged 18-60 years with previously untreated intermediate/high-risk AML or high-risk MDS were randomized for remission induction chemotherapy (1 or 2 cycles) between 1-hr infusion (Arm A) or push injection (Arm B) of clofarabine administered at 10 mg/m2 on days 2, 4, 6, 8 and 10 in combination with Ara-C (100 mg/m2/day on days 1-10) and idarubicin (10 mg/m2/day, on days 1, 3, and 5). One cycle of consolidation including Ara-C and idarubicin was administered in patients who achieved a CR/CRi. Primary endpoint was the CR/CRi rate after 1 or 2 cycles. Results: Among the 62 eligible patients (31 in each randomized arm), 5 had high-risk MDS. Median age was 50 years (range 20-60). The CR/CRi rate after induction was 84% (26 of 31 patients) in each arm (95% CI: 66-95%). During the induction/consolidation phase, 4 toxic deaths occurred in Arm A and one in Arm B. However, documented fungal infections during the induction phase were more frequent in Arm B (29%) than in Arm A (13%). Conclusions: Both low dose clofarabine containing regimens yielded an impressive CR/CRi rate (84%) with acceptable toxicity among patients with intermediate/high-risk AML or high-risk MDS.
Pubblicato
Rilevanza internazionale
Lettera
Esperti anonimi
Settore MED/15 - Malattie del Sangue
English
Con Impact Factor ISI
Selleslag, D., Suciu, S., Meloni, G., Muus, P., Halkes, C., Venditti, A., et al. (2017). Low dose clofarabine in combination with a standard remission induction in patients 18-60 years with previously untreated intermediate and bad risk AML or high risk MDS:combined Phase I/II results of the EORTC/GIMEMA AML-14A Trial. HAEMATOLOGICA [10.3324/haematol.2016.153130].
Selleslag, D; Suciu, S; Meloni, G; Muus, P; Halkes, C; Venditti, A; Ramadan, S; Pruijt, H; Meert, L; Vignetti, M; Marie, J; Wittnebel, S; de Witte, T; Amadori, S; Willemze, R; Baron, F
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/177394
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