A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
Data Collection
Chronic Disease+11
+ Hematologic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: May 1, 2001
Actual date on which the first participant was enrolled.The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. * No previous therapy for CLL. * Expected remaining life span greater than or equal to six months. * 18 years or older. * Willingness and ability to sign an informed consent. Exclusion Criteria: * Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. * History of other malignancy which could affect the diagnosis or assessment of OSI-461. * Previous therapy for CLL. * Use of an investigational medication or device within one month of initiating study therapy. * Concurrent immunotherapy. * Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study). * Any condition or any medication which may interfere with the conduct of the study. * Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. * Evidence of CNS involvement. * Pregnant or nursing women.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Rocky Mountain Cancer Centers
Aurora, United StatesFlorida Oncology Associates
Jacksonville, United StatesOcala Oncology Center
Ocala, United States