Chronic Lymphocytic LeukemiaPhase 1NCT00036257
Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
A Phase 1 study testing CP-461 in people with Chronic Lymphocytic Leukemia, run by Astellas Pharma Inc at 5 sites in United States.
Trial summary
The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia. 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?
- CP-461
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2002to Apr 2003
- Phase
- Phase 1
- 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
- Relapsed or refractory chronic lymphocytic leukemia.
- Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
- Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
- No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
- Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
- Expected remaining life span > or = three months.
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- ECOG performance status 0 - 2.
- 18 years or of legal age.
- Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
- Negative serum pregnancy test, if fertile female.
- Willingness and ability to sign an informed consent document.
Who cannot join
- Evidence of CNS involvement.
- Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- Previous therapy with Campath.
- Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
- Concurrent immunotherapy.
- Concurrent use of steroids.
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- Use of an investigational medication or device within 1 month of initiating study therapy.
- Patients who have had allogeneic bone marrow transplantation.
- Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
- AST or ALT > 2.5 times the upper limit of normal.
- Any condition or any medication which may interfere with the conduct of the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Albany Regional Cancer Center
Albany, New York, 12208
Mary Crowley Medical Research Center (US Oncology)
Dallas, Texas, 75246
Cancer Centers of Florida
Orlando, Florida, 32806
Cancer Care Northwest
Spokane, Washington, 99218
Tyler Cancer Center
Tyler, Texas, 75702
About this study
The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- CP-461
- Keywords
- Chronic Lymphocytic 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.
CP-461Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startMar 2002
- Study completionApr 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cell Pathways, OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036257
- Sponsor's protocol ID
- OSI-461-010
- Status last verified
- Oct 2011
- First submitted
- 8 May 2002
- 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
- Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00036257
- Acronym / sponsor ID
- OSI-461-010
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Leukemia, CLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Cell Pathways, OSI Pharmaceuticals
- Study start
- Mar 2002
- Study completion
- Apr 2003 (actual)
- First posted
- 9 May 2002 (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 purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (11 listed)
- Relapsed or refractory chronic lymphocytic leukemia.
- Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
- Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
- No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
- Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
Key exclusion criteria (11 listed)
- Evidence of CNS involvement.
- Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- Previous therapy with Campath.
- Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
- 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 |
|---|---|---|
| CP-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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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-461 in people with Chronic Lymphocytic Leukemia, run by Astellas Pharma Inc at 5 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 11 inclusion and 11 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 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.