Study

A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte (LGL) Leukemia

Study ID Alternative Stable ID Type
phs000594 Interventional

Study Description

LGL leukemia can be divided into three subsets including the following: αβ or γδT-LGL and NK-LGL leukemia. All three subtypes will be enrolled using a two-stage design. The primary endpoint of the study is assessment of overall clinical response. Correlative laboratory studies will be performed aimed at determining the mechanism of response to treatment. Thirteen participants will be accrued in the first stage at a dose of 300 mg BID administered intermittently every other week (i.e., 7 days on and 7 days off). If there are two or more responders, the protocol will be extended to a second stage of the study and accrual will be extended to 25 evaluable participants. Allowing for 10% rate of ineligibility due to unexpected events and dropout, we will accrue 14 patients in the first stage and 27 patients in total. Participants that withdraw from the study for reason unrelated to toxicity, will be replaced. There are two potential stopping rules for toxicity.

If 3 or more participants out of the 13 enrolled in the first stage experiences grade IV ... (Show More)

Archive Link Archive Accession
dbGaP phs000594

Who archives the data?

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