title: Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma.
abstract: Despite initial responses > 90% with fludarabine and rituximab-based regimens, patients with chronic lymphocytic leukemia (CLL) invariably relapse and require further treatment. Ofatumumab and bendamustine have each shown efficacy in relapsed/refractory CLL with overall response rates (ORRs) of 58% and 76%, respectively. Given excellent data with bendamustine and rituximab in relapsed/refractory CLL/small lymphocytic lymphoma (SLL), this phase II study evaluated the combination of ofatumumab and bendamustine in previously treated patients. Patients received ofatumumab 300 mg intravenously (IV) day - 7, followed by ofatumumab 1000 mg IV day 1 and bendamustine 70 mg/m(2) days 1 and 2 of each 28-day cycle. Patients received 4-6 cycles depending on number of prior therapies, as long as well-tolerated or until progression. Of 10 patients enrolled, the ORR was 40% and complete response rate was 20%. The median progression-free and overall survivals were 8.1 months and 16.2 months. Three patients developed Richter transformation. The study was closed early due to unexpected adverse events including infusion-related reactions, infection and neurotoxicity.
authors.affiliation: Department of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital , Washington, DC , USA.
authors.forename: Chaitra
authors.initials: C
authors.lastname: Ujjani
authors.forename: Pari
authors.initials: P
authors.lastname: Ramzi
authors.forename: Edmund
authors.initials: E
authors.lastname: Gehan
authors.forename: Hongkun
authors.initials: H
authors.lastname: Wang
authors.forename: Yiru
authors.initials: Y
authors.lastname: Wang
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007239:Infections / Q000139:chemically induced; D057967:Infusions, Intraventricular; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069461:Bendamustine Hydrochloride; C527517:ofatumumab
keywords: CLL; Ofatumumab; SLL; bendamustine