Long-term durable remission by cladribine followed by rituximab in patients with hairy cell leukaemia: update of a phase II trial.
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/m(2) was given intravenously (IV) daily for 5 d and was followed approximately 1 month later with rituximab 375 mg/m(2) 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.
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Dai
D
Chihara
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hagop
H
Kantarjian
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan
S
O'Brien
Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jeffrey
J
Jorgensen
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sherry
S
Pierce
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Stefan
S
Faderl
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alessandra
A
Ferrajoli
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rebecca
R
Poku
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Preetesh
P
Jain
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Phillip
P
Thompson
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mark
M
Brandt
Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rajyalakshmi
R
Luthra
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jan
J
Burger
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Michael
M
Keating
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Farhad
F
Ravandi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017338:Cladribine / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007943:Leukemia, Hairy Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual / Q000188:drug therapy; D012008:Recurrence; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage*
D000970:Antineoplastic Agents; D017338:Cladribine; D000069283:Rituximab
Hairy cell leukaemia; cladribine; phase II study; rituximab