Polycythemia VeraPhase 2NCT01120821
Treatment of Polycythemia Vera With Gleevec
A Phase 2 study testing Gleevec in people with Polycythemia Vera, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Gleevec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2007
- 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
- Patients have diagnosis of Polycythemia Vera (PV). Patients may have newly diagnosed PV.
- Patients may have previously interferon-alfa treated PV with documented resistance, refractoriness or intolerance to interferon-alfa.
- Patients may have PV with inadequate control on hydroxyurea.
- Performance status of 0, 1, or 2
- Adequate end organ function, defined as the following:
- total bilirubin <1.5 x upper limit of the normal range (ULN)
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- SGOT (AST) and SGPT (ALT) < 2.5 x ULN
- creatinine < 1.5 x ULN
- ANC > 1.5 x 109/L
- Written voluntary informed consent.
Who cannot join
- Female patients who are pregnant or breast-feeding.
- Patients receiving busulfan within 6 weeks of Study Day 1.
- Patients receiving interferon-alpha within 4 weeks of Study Day 1.
- Patients receiving hydroxyurea within 2 weeks of Study Day 1.
- Patients with Grade III or IV cardiac problems as defined by the New York Heart Association Criteria.
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
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- Patients previously treated with Gleevec.
- Serum erythropoietin level > or = 25 units/microliter
- Abnormal O2 saturation (by pulse oximetry) or arterial pO2 (by arterial blood gas).
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.
Read the detailed description
Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.
- Conditions
- Polycythemia Vera
- Being tested
- Gleevec
- Keywords
- PV
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GleevecDrug
Also called STI-571
400 mg once daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Study drug | Experimental | Gleevec treatment Receives: Drug: Gleevec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilization of hematocrit
Measured: Weekly for the first six week of treatment, then monthly for one year from study entry.
Platelet count maintenance a therapeutic range.
Measured: Weekly for the first six weeks of treatment, then monthly for one year from study entry.
Secondary outcomes (2)
Splenomegaly (if existent)
Measured: Weekly for the first six weeks of treatment, then montly for one year from study entry.
Quality of life, performance status, side effects and complications during treatment.
Measured: Weekly for the first six weeks of treatment, then montly for one year from study entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startAug 2002
- Primary completionJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Richard Silver, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120821
- Sponsor's protocol ID
- 0702-375
- Other IDs
- CSTI571AUS41
- Status last verified
- May 2010
- First submitted
- 7 May 2010
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
- ClinicalTrials.gov ID
- NCT01120821
- Acronym / sponsor ID
- 0702-375
- Conditions
- Polycythemia Vera
- Keywords
- PV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 11 May 2010 (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 purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.
Detailed description
Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study drug | Experimental | Drug: GleevecGleevec treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients have diagnosis of Polycythemia Vera (PV). Patients may have newly diagnosed PV.
- Patients may have previously interferon-alfa treated PV with documented resistance, refractoriness or intolerance to interferon-alfa.
- Patients may have PV with inadequate control on hydroxyurea.
- Performance status of 0, 1, or 2
- Adequate end organ function, defined as the following:
Key exclusion criteria (9 listed)
- Female patients who are pregnant or breast-feeding.
- Patients receiving busulfan within 6 weeks of Study Day 1.
- Patients receiving interferon-alpha within 4 weeks of Study Day 1.
- Patients receiving hydroxyurea within 2 weeks of Study Day 1.
- Patients with Grade III or IV cardiac problems as defined by the New York Heart Association Criteria.
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 |
|---|---|---|
| GleevecAlso: STI-571400 mg once daily for 12 months | Drug | Study drug |
Primary outcome
Stabilization of hematocrit
Time frame: Weekly for the first six week of treatment, then monthly for one year from study entry.
Platelet count maintenance a therapeutic range.
Time frame: Weekly for the first six weeks of treatment, then monthly for one year from study entry.
2 secondary outcomes
Splenomegaly (if existent)
Time frame: Weekly for the first six weeks of treatment, then montly for one year from study entry.
Quality of life, performance status, side effects and complications during treatment.
Time frame: Weekly for the first six weeks of treatment, then montly for one year from study entry.
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 May 2010.
Related trials for Polycythemia Vera
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RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
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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.
Richard Silver, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gleevec in people with Polycythemia Vera, run by Weill Medical College of Cornell University at 1 site 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 10 inclusion and 9 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 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Stabilization of hematocrit (time frame: Weekly for the first six week of treatment, then monthly for one year from study entry.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 May 2010.