title: Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia.
abstract: We conducted this study to determine the feasibility and safety of cladribine followed by rituximab in patients with hairy cell leukemia including the vari-ant form (HCLv). Cladribine 5.6 mg/m² given IV over 2 hours daily for 5 days was followed ∼ 1 month later with rituximab 375 mg/m² 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 × 10⁹/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.
authors.affiliation: Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA. fravandi@mdanderson.org
authors.forename: Farhad
authors.initials: F
authors.lastname: Ravandi
authors.forename: Susan
authors.initials: S
authors.lastname: O'Brien
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Jorgensen
authors.forename: Sherry
authors.initials: S
authors.lastname: Pierce
authors.forename: Stefan
authors.initials: S
authors.lastname: Faderl
authors.forename: Alessandra
authors.initials: A
authors.lastname: Ferrajoli
authors.forename: Charles
authors.initials: C
authors.lastname: Koller
authors.forename: Pramoda
authors.initials: P
authors.lastname: Challagundla
authors.forename: Sergernne
authors.initials: S
authors.lastname: York
authors.forename: Mark
authors.initials: M
authors.lastname: Brandt
authors.forename: Rajyalakshmi
authors.initials: R
authors.lastname: Luthra
authors.forename: Jan
authors.initials: J
authors.lastname: Burger
authors.forename: Deborah
authors.initials: D
authors.lastname: Thomas
authors.forename: Michael
authors.initials: M
authors.lastname: Keating
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017338:Cladribine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007943:Leukemia, Hairy Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D017338:Cladribine; D000069283:Rituximab