TY - JOUR
T1 - Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia
AU - Ravandi, Farhad
AU - O'Brien, Susan
AU - Jorgensen, Jeffrey
AU - Pierce, Sherry
AU - Faderl, Stefan
AU - Ferrajoli, Alessandra
AU - Koller, Charles
AU - Challagundla, Pramoda
AU - York, Sergernne
AU - Brandt, Mark
AU - Luthra, Rajyalakshmi
AU - Burger, Jan
AU - Thomas, Deborah
AU - Keating, Michael
AU - Kantarjian, Hagop
PY - 2011/10/6
Y1 - 2011/10/6
N2 - We conducted this study to determine the feasibility and safety of cladribine followed by rituximab in patients with hairy cell leukemia including the variant form (HCLv). Cladribine 5.6 mg/m2given IV over 2 hours daily for 5 days was followed ∼ 1 month later with rituximab 375 mg/m 2 IV weekly for 8 weeks. Responses were recorded and BM minimal residual disease (MRD) was evaluated after the completion of rituximab. Thirty-six patients have been treated including 5 with HCLv. Median age was 57 years (range, 37-89). All patients (100%) have achieved complete response (CR), defined as presence of no hairy cells in BM and blood with normalization of counts (absolute neutrophil count [ANC] > 1.5 × 109/L, hemoglobin [Hgb] > 12.0 g/dL, platelets [PLT] > 100 × 10 9/L), as well as resolution of splenomegaly. There were no grade 3 or 4 nonhematologic adverse events directly related to the treatment. Only 1 patient (with HCLv) has relapsed; median CR duration has not been reached (range,1+-63+ months). Three patients with HCLv died including 1 with relapsed disease and 2 from unrelated malignancies. Median survival duration has not been reached (range, 2+-64+ months). Treatment with cladribine followed by rituximab is effective tk;4and may increase CR rate. This study was registered at www.clinicaltrials.gov as NCT00412594.
AB - We conducted this study to determine the feasibility and safety of cladribine followed by rituximab in patients with hairy cell leukemia including the variant form (HCLv). Cladribine 5.6 mg/m2given IV over 2 hours daily for 5 days was followed ∼ 1 month later with rituximab 375 mg/m 2 IV weekly for 8 weeks. Responses were recorded and BM minimal residual disease (MRD) was evaluated after the completion of rituximab. Thirty-six patients have been treated including 5 with HCLv. Median age was 57 years (range, 37-89). All patients (100%) have achieved complete response (CR), defined as presence of no hairy cells in BM and blood with normalization of counts (absolute neutrophil count [ANC] > 1.5 × 109/L, hemoglobin [Hgb] > 12.0 g/dL, platelets [PLT] > 100 × 10 9/L), as well as resolution of splenomegaly. There were no grade 3 or 4 nonhematologic adverse events directly related to the treatment. Only 1 patient (with HCLv) has relapsed; median CR duration has not been reached (range,1+-63+ months). Three patients with HCLv died including 1 with relapsed disease and 2 from unrelated malignancies. Median survival duration has not been reached (range, 2+-64+ months). Treatment with cladribine followed by rituximab is effective tk;4and may increase CR rate. This study was registered at www.clinicaltrials.gov as NCT00412594.
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U2 - 10.1182/blood-2011-04-351502
DO - 10.1182/blood-2011-04-351502
M3 - Article
C2 - 21821712
AN - SCOPUS:80053649383
SN - 0006-4971
VL - 118
SP - 3818
EP - 3823
JO - Blood
JF - Blood
IS - 14
ER -