Concomitant administration of chlorambucil limits dose intensity of fludarabine in previously treated patients with chronic lymphocytic leukemia Journal Article
| Authors: | Weiss, M.; Spiess, T.; Berman, E.; Kempin, S. |
| Article Title: | Concomitant administration of chlorambucil limits dose intensity of fludarabine in previously treated patients with chronic lymphocytic leukemia |
| Abstract: | Fifteen patients with chronic lymphocytic leukemia (CLL) were treated in a phase I-II study of chlorambucil with an escalating dose of fludarabine. The study was designed to identify a maximum tolerated dose (MTD) of fludarabine given in conjunction with a constant dose of chlorambucil. Patients were eligible for study if they had Rai intermediate or high-risk disease which had relapsed from or was refractory to conventional treatment. The initial cohort of patients received fludarabine 10 mg/m2/d days 1-5 and chlorambucil 20 mg/m2 days 1 and 15. Cycles were repeated every 28 days. Unacceptable toxicity was encountered in this cohort. The protocol was then modified to give chlorambucil 20 mg/m2 on day 1 (only). At this chlorambucil dose, cohorts of three patients were treated with fludarabine 10, 15, and 20 mg/m2/d x 5 days. The predominant toxicity was thrombocytopenia with 73% experiencing grade 23 toxicity. The dose-limiting non-hematologic toxicity was infection. We identified an MTD of fludarzbine of 15mg/m2/dx5 days when given with chlorambucil 20 mg/m2 for this group of patients. One patient achieved a CR and three patients achieved a PR for a total response rate of 27%. We conclude that concomitant administration of chlorambucil limits the dose intensity of fludarabine which can be administered to previously treated patients with CLL. |
| Keywords: | adult; clinical article; aged; fludarabine; clinical trial; neurotoxicity; infection; liver toxicity; nephrotoxicity; phase 2 clinical trial; anemia; bleeding; blood toxicity; nausea; stomatitis; thrombocytopenia; vomiting; fever; phase 1 clinical trial; chronic lymphatic leukemia; chlorambucil; granulocytopenia; leukemia remission; human; male; female; priority journal; article |
| Journal Title: | Leukemia |
| Volume: | 8 |
| Issue: | 8 |
| ISSN: | 0887-6924 |
| Publisher: | Nature Publishing Group |
| Date Published: | 1994-08-01 |
| Start Page: | 1290 |
| End Page: | 1293 |
| Language: | English |
| PROVIDER: | scopus |
| PUBMED: | 8057664 |
| DOI/URL: | |
| Notes: | Export Date: 14 January 2019 -- Article -- CODEN: LEUKE C2 -- Source: Scopus |
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