TY - JOUR
T1 - Long-term durable remission by cladribine followed by rituximab in patients with hairy cell leukaemia
T2 - update of a phase II trial
AU - Chihara, Dai
AU - Kantarjian, Hagop
AU - O'Brien, Susan
AU - Jorgensen, Jeffrey
AU - Pierce, Sherry
AU - Faderl, Stefan
AU - Ferrajoli, Alessandra
AU - Poku, Rebecca
AU - Jain, Preetesh
AU - Thompson, Phillip
AU - Brandt, Mark
AU - Luthra, Rajyalakshmi
AU - Burger, Jan
AU - Keating, Michael
AU - Ravandi, Farhad
N1 - Publisher Copyright:
© 2016 John Wiley & Sons Ltd
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Nucleoside analogues are highly active in patients with hairy cell leukaemia (HCL); however, patients continue to relapse. This phase II study evaluated the efficacy and safety of cladribine followed by rituximab in patients with untreated HCL (N = 59), relapsed HCL (N = 14) and HCL variant (HCLv, N = 7). Cladribine 5·6 mg/m2 was given intravenously (IV) daily for 5 d and was followed approximately 1 month later with rituximab 375 mg/m2 IV weekly for 8 weeks. Complete response rate in patients with untreated HCL, relapsed HCL and HCLv was 100%, 100% and 86%, respectively. With a median follow up of 60 months, 5-year failure-free survival (FFS) in patients with untreated HCL, relapsed HCL and HCLv was 95%, 100% and 64%, respectively. Median duration of response to the cladribine followed by rituximab was significantly longer than the first-line cladribine single agent in patients who received this treatment as second-line treatment (72 months vs not reached, P = 0·004). Almost all patients (94%) achieved negative minimal residual disease (MRD) after the treatment. Positive MRD during the follow up did not necessarily result in clinically relevant relapse. Cladribine followed by rituximab is highly effective even in patients with relapsed disease and HCLv, and can achieve durable remission.
AB - Nucleoside analogues are highly active in patients with hairy cell leukaemia (HCL); however, patients continue to relapse. This phase II study evaluated the efficacy and safety of cladribine followed by rituximab in patients with untreated HCL (N = 59), relapsed HCL (N = 14) and HCL variant (HCLv, N = 7). Cladribine 5·6 mg/m2 was given intravenously (IV) daily for 5 d and was followed approximately 1 month later with rituximab 375 mg/m2 IV weekly for 8 weeks. Complete response rate in patients with untreated HCL, relapsed HCL and HCLv was 100%, 100% and 86%, respectively. With a median follow up of 60 months, 5-year failure-free survival (FFS) in patients with untreated HCL, relapsed HCL and HCLv was 95%, 100% and 64%, respectively. Median duration of response to the cladribine followed by rituximab was significantly longer than the first-line cladribine single agent in patients who received this treatment as second-line treatment (72 months vs not reached, P = 0·004). Almost all patients (94%) achieved negative minimal residual disease (MRD) after the treatment. Positive MRD during the follow up did not necessarily result in clinically relevant relapse. Cladribine followed by rituximab is highly effective even in patients with relapsed disease and HCLv, and can achieve durable remission.
KW - Hairy cell leukaemia
KW - cladribine
KW - phase II study
KW - rituximab
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U2 - 10.1111/bjh.14129
DO - 10.1111/bjh.14129
M3 - Article
C2 - 27301277
AN - SCOPUS:84987720558
SN - 0007-1048
VL - 174
SP - 760
EP - 766
JO - British Journal of Haematology
JF - British Journal of Haematology
IS - 5
ER -