Journal
AMERICAN JOURNAL OF HEMATOLOGY
Volume 90, Issue 4, Pages 327-333Publisher
WILEY
DOI: 10.1002/ajh.23946
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Funding
- NIH/NCI [U01CA076576, 1R21 CA 133875-01A1, P50 CA144250]
- National Cancer Institute of the National Institutes of Health [U01CA076576]
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Flavopiridol and lenalidomide have activity in refractory CLL without immunosuppression or opportunistic infections seen with other therapies. We hypothesized that flavopiridol treatment could adequately de-bulk disease prior to lenalidomide therapy, decreasing the incidence of tumor flare with higher doses of lenalidomide. In this Phase I study, the maximum tolerated dose was not reached with treatment consisting of flavopiridol 30 mgm(-2) intravenous bolus (IVB)+30 mgm(-2) continuous intravenous infusion (CIVI) cycle (C) 1 day (D) 1 and 30 mgm(-2) IVB+50 mgm(-2) CIVI C1 D8,15 and C2-8 D3,10,17 with lenalidomide 15 mg orally daily C2-8 D1-21. There was no unexpected toxicity seen, including no increased tumor lysis, tumor flare (even at higher doses of lenalidomide) or opportunistic infection. Significant clinical activity was demonstrated, with a 51% response rate in this group of heavily pretreated patients. Biomarker testing confirmed association of mitochondrial priming of the BH3 only peptide Puma with response.Am. J. Hematol. 90:327-333, 2015. (c) 2015 Wiley Periodicals, Inc.
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