Abstract | PURPOSE: PATIENTS AND METHODS: Patients had received at least one prior fludarabine-containing regimen and were stratified on the basis of prior fludarabine response, number of prior regimens, and duration of response to last prior therapy. Patients were randomly assigned to 28-day cycles of fludarabine 25 mg/m2/d plus cyclophosphamide 250 mg/m2/d administered intravenously for 3 days with or without oblimersen 3 mg/kg/d as a 7-day continuous intravenous infusion (beginning 4 days before chemotherapy) for up to six cycles. The primary end point was the proportion of patients who achieved complete response (CR) or nodular partial response (nPR). RESULTS: CONCLUSION: The addition of oblimersen to fludarabine plus cyclophosphamide significantly increases the CR/nPR rate in patients with relapsed or refractory CLL (particularly fludarabine-sensitive patients), as well as response duration among patients who achieve CR/nPR.
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Authors | Susan O'Brien, Joseph O Moore, Thomas E Boyd, Loree M Larratt, Aleksander Skotnicki, Benjamin Koziner, Asher A Chanan-Khan, John F Seymour, R Gregory Bociek, Steve Pavletic, Kanti R Rai |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 25
Issue 9
Pg. 1114-20
(Mar 20 2007)
ISSN: 1527-7755 [Electronic] United States |
PMID | 17296974
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Oligonucleotides, Antisense
- Thionucleotides
- oblimersen
- Cyclophosphamide
- Vidarabine
- fludarabine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(administration & dosage)
- Antineoplastic Agents, Alkylating
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Cyclophosphamide
(administration & dosage)
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Genes, bcl-2
- Humans
- Kaplan-Meier Estimate
- Leukemia, Lymphocytic, Chronic, B-Cell
(drug therapy, genetics, mortality)
- Male
- Middle Aged
- Oligonucleotides, Antisense
(administration & dosage)
- Proportional Hazards Models
- Recurrence
- Thionucleotides
(administration & dosage)
- Time Factors
- Treatment Failure
- Treatment Outcome
- Vidarabine
(administration & dosage, analogs & derivatives)
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