Completed

A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

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What is being tested

OSI-461

Drug
Who is being recruted

Chronic Lymphocytic Leukemia

Over 18 Years
+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2001

See protocol details

Summary

Principal SponsorAstellas Pharma Inc
Last updated: October 17, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2001Actual date on which the first participant was enrolled.

The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients. 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: October 17, 2011
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Lymphocytic Leukemia
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
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

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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 AssociatesPhoenix, United StatesSee the location
Suspended
Rocky Mountain Cancer CentersAurora, United States
Suspended
Florida Oncology AssociatesJacksonville, United States
Suspended
Ocala Oncology CenterOcala, United States
Completed15 Study Centers