Tipifarnib in Treating Patients With Anemia or Neutropenia and Large Granular Lymphocyte Leukemia
|ClinicalTrials.gov Identifier: NCT00360776|
Recruitment Status : Terminated
First Posted : August 7, 2006
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia T-cell Large Granular Lymphocyte Leukemia||Drug: tipifarnib Other: laboratory biomarker analysis||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte (LGL) Leukemia|
|Actual Study Start Date :||June 2, 2006|
|Actual Primary Completion Date :||May 14, 2007|
Experimental: Arm I
Patients will receive tipifarnib by mouth twice a day for 3 weeks. Treatment may repeat every 4 weeks for up to eight courses.
Patients will undergo blood collection periodically for laboratory studies. After finishing treatment, patients will be evaluated every 6 months for 5 years.
Other Names:Other: laboratory biomarker analysis
- Response rates to tipifarib defined as the proportion of patients achieving a complete response (CCR) or partial response (PR) [ Time Frame: Up to 5 years ]
- Changes in Ras/ERK and NK receptor expression [ Time Frame: Baseline to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360776
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Thomas Loughran||Case Comprehensive Cancer Center|