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A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte (LGL) Leukemia
This phase II trial is studying how well tipifarnib works in treating patients with anemia or neutropenia and large granular lymphocyte leukemia. Tipifarnib may stop the growth of leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes needed for cancer cell growth.
PRIMARY OBJECTIVES: I. Estimate the complete response rate, partial response rate, and overall response rate in patients with natural killer (NK)- or T-cell-large granular lymphocyte (LGL) leukemia who present with neutropenia or anemia treated with tipifarnib. SECONDARY OBJECTIVES: I. Determine the toxicity of tipifarnib in these patients. II. Determine the mechanism of treatment responses in these patients through correlative laboratory studies. OUTLINE: Patients are stratified by disease type (natural killer-large granular lymphocyte \[LGL\] leukemia vs T-cell-LGL leukemia). Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated after completion of course 4. Patients achieving complete response receive 1 additional course of treatment. Patients achieving partial response receive 4 additional courses of treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection periodically during study for response mechanism studies and other biomarker correlative studies, including mutations of K-ras and N-ras genes. After completion of study treatment, patients are followed every 6 months for 5 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Case Western Reserve University
Cleveland, Ohio, United States
Start Date
June 2, 2006
Primary Completion Date
May 14, 2007
Last Updated
April 5, 2017
25
ACTUAL participants
tipifarnib
DRUG
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT05141682
NCT02168140
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT01769222