title: Combined fludarabine and rituximab for low grade lymphoma and chronic lymphocytic leukemia.
abstract: As both fludarabine and rituximab are active against indolent lymphoproliferative disorders, we have studied the combination of fludarabine and rituximab in patients with low-grade lymphoma and chronic lymphocytic leukemia (CLL) in phase I/II fashion. Of 33 patients enrolled, 21(63.6%) had low-grade lymphoma and 12 (36.4%) had CLL. They received fludarabine 30 mg/m2 on days 1-4 and rituximab 125, 250 or 375 mg/m2 on day 5 at intervals of 28 days to a maximum of 8 cycles. Three patients were removed from the study because of rituximab-associated anaphylaxis and four because of prolonged hematopoietic toxicity. Toxicity and responsiveness did not differ at the different dose levels of rituximab. For 29 evaluable patients, responses were seen in 82.8% and complete responses in 34.5%. Of 7 responding patients not referred for stem cell transplantation, 6 remain in complete remission at a median follow-up of 16 months (range 4-30 months). Of 13 previously untreated patients, all responded and 46.2% had a complete response. Of 16 previously treated patients, 68.5% responded and 25% had a complete response. The combination of fludarabine and rituximab has major activity and acceptable toxicity in patients with low-grade lymphoma and CLL.
authors.affiliation: New York Presbyterian Hospital. Columbia Campus, New York, NY 10032, USA. dgs5@columbia.edu
authors.forename: David G
authors.initials: DG
authors.lastname: Savage
authors.forename: Neil S
authors.initials: NS
authors.lastname: Cohen
authors.forename: Charles S
authors.initials: CS
authors.lastname: Hesdorffer
authors.forename: Daniel
authors.initials: D
authors.lastname: Heitjan
authors.forename: Martin W
authors.initials: MW
authors.lastname: Oster
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Garrett
authors.forename: Michael
authors.initials: M
authors.lastname: Bar
authors.forename: Salvatore
authors.initials: S
authors.lastname: del Prete
authors.forename: Robert
authors.initials: R
authors.lastname: March
authors.forename: Mathew
authors.initials: M
authors.lastname: Lonberg
authors.forename: Susan
authors.initials: S
authors.lastname: Talbot
authors.forename: J Gregory
authors.initials: JG
authors.lastname: Mears
authors.forename: Michael
authors.initials: M
authors.lastname: Flamm
authors.forename: Robert N
authors.initials: RN
authors.lastname: Taub
authors.forename: Gwen
authors.initials: G
authors.lastname: Nichols
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000707:Anaphylaxis / Q000209:etiology; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy / Q000628:therapy*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation; D012074:Remission Induction; D000069283:Rituximab; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000964:Antimetabolites, Antineoplastic; D000069283:Rituximab; D014740:Vidarabine; C024352:fludarabine