Chronic Lymphocytic LeukemiaPhase 2NCT00073489
A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing OSI-461 in people with Chronic Lymphocytic Leukemia, run by Astellas Pharma Inc at 15 sites in United States.
Trial summary
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- OSI-461
- How many people
- 23 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2001to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
Southwest Regional Cancer Center
Austin, Texas, 78705
Iowa Oncology Associates
Cedar Rapids, Iowa, 52403
Dayton Oncology/Hematology Consultants
Dayton, Ohio, 45439
Willamette Valley Cancer Center
Eugene, Oregon, 97401
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
Florida Oncology Associates
Jacksonville, Florida, 32207
Oncology/Hematology Associates of Kansas City
Kansas City, Missouri, 64111
Ocala Oncology Center
Ocala, Florida, 34474
Arizona Hematology & Oncology Associates
Phoenix, Arizona, 85012
Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24101
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229
Cancer Care Northwest
Spokane, Washington, 99202
Tyler Cancer Center
Tyler, Texas, 75702
Piedmont Hem Onc Assoc, P.A.
Winston-Salem, North Carolina, 27103
About this study
Official title: A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.
Read the detailed description
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- OSI-461
- Keywords
- chronic leukemia, leukemia, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-461Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2003 (estimated)
- Study startMay 2001
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073489
- Sponsor's protocol ID
- OSI-461-005
- Status last verified
- Oct 2011
- First submitted
- 21 Nov 2003
- Last updated
- 17 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00073489
- Acronym / sponsor ID
- OSI-461-005
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- chronic leukemia, leukemia, CLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Study start
- May 2001
- Study completion
- Dec 2003 (actual)
- First posted
- 25 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSI-461 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSI-461 in people with Chronic Lymphocytic Leukemia, run by Astellas Pharma Inc at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.