title: Efficacy of rituximab and cladribine in patients with chronic lymphocytic leukemia and feasibility of stem cell mobilization: a prospective multicenter phase II trial (protocol SAKK 34/02).
abstract: This phase II trial investigated rituximab and cladribine in chronic lymphocytic leukemia. Four induction cycles, comprising cladribine (0.1 mg/kg/day days 1-5, cycles 1-4) and rituximab (375 mg/m(2) day 1, cycles 2-4), were given every 28 days. Stem cell mobilization (rituximab 375 mg/m(2) days 1 and 8; cyclophosphamide 4 g/m(2) day 2; and granulocyte colony-stimulating factor 10 microg/kg/day, from day 4) was performed in responders. Of 42 patients, nine achieved complete remission (CR), 15 very good partial remission, and two nodular partial remission (overall response rate 62%). Stem cell mobilization and harvesting (> or = 2 x 10(6) stem cells/kg body weight) were successful in 12 of 20 patients. Rituximab infusion-related adverse events were moderate. The main grade 3/4 adverse events during induction were neutropenia and lymphocytopenia. Rituximab plus cladribine was effective; however, the CR rate was modest and stem cell harvest was impaired in a large number of responding patients.
authors.affiliation: Department of Medical Oncology, University of Bern, Inselspital, 3010 Bern, Switzerland.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Leupin
authors.forename: Jan C
authors.initials: JC
authors.lastname: Schuller
authors.forename: Max
authors.initials: M
authors.lastname: Solenthaler
authors.forename: Dominik
authors.initials: D
authors.lastname: Heim
authors.forename: Alicia
authors.initials: A
authors.lastname: Rovo
authors.forename: Kurt
authors.initials: K
authors.lastname: Beretta
authors.forename: Michael
authors.initials: M
authors.lastname: Gregor
authors.forename: Mario J
authors.initials: MJ
authors.lastname: Bargetzi
authors.forename: Peter
authors.initials: P
authors.lastname: Brauchli
authors.forename: Andreas
authors.initials: A
authors.lastname: Himmelmann
authors.forename: Silvia
authors.initials: S
authors.lastname: Hanselmann
authors.forename: Reinhard
authors.initials: R
authors.lastname: Zenhäusern
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017338:Cladribine / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D000069283:Rituximab; D019172:Transplantation Conditioning; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D016179:Granulocyte Colony-Stimulating Factor; D017338:Cladribine; D000069283:Rituximab; D003520:Cyclophosphamide