Completed
A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
What is being tested
Data Collection
Who is being recruted
Chronic Disease+13
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: May 2001
Summary
Principal SponsorAstellas Pharma Inc
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
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.
Official TitleA Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
Principal SponsorAstellas Pharma Inc
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
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
Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellDisease Attributes
Criteria
5 inclusion criteria required to participate
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.
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10 exclusion criteria prevent from participating
Pregnant or nursing women.
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.
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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
Suspended
Arizona Hematology & Oncology Associates
Phoenix, United StatesOpen Arizona Hematology & Oncology Associates in Google MapsSuspended
Rocky Mountain Cancer Centers
Aurora, United StatesSuspended
Florida Oncology Associates
Jacksonville, United StatesSuspended
Ocala Oncology Center
Ocala, United StatesCompleted15 Study Centers