Clofarabine (CLO) and cyclophosphamide (CY) combinations were tested in late stage refractory/relapsed (R/R) acute lymphoblastic leukemia (ALL) with disappointing results and high-grade toxicity. We designed a sequential 5-day combination of CLO 40 mg/m(2)/d plus CY 400 mg/m(2)/d as first salvage for Philadelphia-negative ALL patients refractory or relapsed until 24 months from complete remission (CR). Primary endpoint was an overall response rate (ORR) >= 40%. Among 26 study patients (median age 40.5 years) ORR was 57.6% (CR with complete [n = 8] or incomplete [n = 7] hematologic recovery). Despite severe myelotoxicity, no dose-limiting toxicity suggested de-intensification of CLO schedule. With a median follow-up of 17.0 months, median and 1-year overall and disease-free survival were 6.5 months and 28.6%, and 3.7 months and 28.1%, respectively. This association was tolerable and more effective in patients younger than 40 years with B-precursor ALL, longer first CR, not previously transplanted and achieving CR with full hematological recovery.

Phase II trial with sequential clofarabine and cyclophosphamide for refractory and relapsed philadelphia-negative adult acute lymphoblastic leukemia. Results of the GIMEMA LAL 1610 protocol / Bassan, R.; Fumagalli, M.; Chiaretti, S.; Audisio, E.; Cascavilla, N.; Paolini, S.; Delia, M.; Cerqui, E.; Mico, C.; Fabbiano, F.; Canichella, M.; Scattolin, A. M.; Perfetti, P.; Paoloni, F.; Iodice, M.; Vitale, A.; Della Starza, I.; Fazi, P.; Vignetti, M.; Foa, R.. - In: LEUKEMIA & LYMPHOMA. - ISSN 1042-8194. - (2019), pp. 1-11-11. [10.1080/10428194.2019.1639170]

Phase II trial with sequential clofarabine and cyclophosphamide for refractory and relapsed philadelphia-negative adult acute lymphoblastic leukemia. Results of the GIMEMA LAL 1610 protocol

Chiaretti S.;Canichella M.;Della Starza I.;Fazi P.;Vignetti M.;Foa R.
2019

Abstract

Clofarabine (CLO) and cyclophosphamide (CY) combinations were tested in late stage refractory/relapsed (R/R) acute lymphoblastic leukemia (ALL) with disappointing results and high-grade toxicity. We designed a sequential 5-day combination of CLO 40 mg/m(2)/d plus CY 400 mg/m(2)/d as first salvage for Philadelphia-negative ALL patients refractory or relapsed until 24 months from complete remission (CR). Primary endpoint was an overall response rate (ORR) >= 40%. Among 26 study patients (median age 40.5 years) ORR was 57.6% (CR with complete [n = 8] or incomplete [n = 7] hematologic recovery). Despite severe myelotoxicity, no dose-limiting toxicity suggested de-intensification of CLO schedule. With a median follow-up of 17.0 months, median and 1-year overall and disease-free survival were 6.5 months and 28.6%, and 3.7 months and 28.1%, respectively. This association was tolerable and more effective in patients younger than 40 years with B-precursor ALL, longer first CR, not previously transplanted and achieving CR with full hematological recovery.
2019
acute lymphoblastic leukemia; Chemotherapeutic approaches; clofarabine
01 Pubblicazione su rivista::01a Articolo in rivista
Phase II trial with sequential clofarabine and cyclophosphamide for refractory and relapsed philadelphia-negative adult acute lymphoblastic leukemia. Results of the GIMEMA LAL 1610 protocol / Bassan, R.; Fumagalli, M.; Chiaretti, S.; Audisio, E.; Cascavilla, N.; Paolini, S.; Delia, M.; Cerqui, E.; Mico, C.; Fabbiano, F.; Canichella, M.; Scattolin, A. M.; Perfetti, P.; Paoloni, F.; Iodice, M.; Vitale, A.; Della Starza, I.; Fazi, P.; Vignetti, M.; Foa, R.. - In: LEUKEMIA & LYMPHOMA. - ISSN 1042-8194. - (2019), pp. 1-11-11. [10.1080/10428194.2019.1639170]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1329865
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