Polycythemia VeraPhase 2NCT00430066
Effects of Imatinib Mesylate in Polycythemia Vera
A Phase 2 study testing Imatinib Mesylate in people with Polycythemia Vera, run by Niguarda Hospital.
Trial summary
The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera. The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to… 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?
- Imatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Sep 2012
- 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 Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
- Age >18 years
- Signed written informed consent form
Who cannot join
- Pregnancy or breast-feeding
- Creatinine >3 max NV
- Bilirubin >3 max NV
- AST/ALT >3 max NV
- Concomitant and severe psychiatric disorder
- Concomitant neoplastic disease
About this study
Official title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.
The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.
Read the detailed description
Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
- Conditions
- Polycythemia Vera
- Being tested
- Imatinib Mesylate
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
400 mg/die for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate | Experimental | 400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness) Receives: Drug: Imatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Haematocrit to less than 45%.
Measured: 6-12 months
Secondary outcomes (5)
Response duration
Measured: 6-12 months
Safety profile
Measured: 6-12 months
Reduction in platelet count and spleen size
Measured: 6-12 months
Reduction of incidence phlebotomies.
Measured: 6-12 months
Symptoms improvement in patients.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2009
- Study completionSep 2012
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.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrica Morra, MD, Study director, Divisione di Ematologia - Ospedale Niguarda Ca' Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430066
- Sponsor's protocol ID
- CSTI571POLIVERA
- Status last verified
- Oct 2014
- First submitted
- 31 Jan 2007
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
- ClinicalTrials.gov ID
- NCT00430066
- Acronym / sponsor ID
- CSTI571POLIVERA
- Conditions
- Polycythemia Vera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Feb 2007 (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 study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.
The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.
Detailed description
Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate | Experimental | Drug: Imatinib Mesylate400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
- Age >18 years
- Signed written informed consent form
Key exclusion criteria (6 listed)
- Pregnancy or breast-feeding
- Creatinine >3 max NV
- Bilirubin >3 max NV
- AST/ALT >3 max NV
- Concomitant and severe psychiatric disorder
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 |
|---|---|---|
| Imatinib Mesylate400 mg/die for 6 months | Drug | Imatinib Mesylate |
Primary outcome
Reduction of Haematocrit to less than 45%.
Time frame: 6-12 months
5 secondary outcomes
Response duration
Time frame: 6-12 months
Safety profile
Time frame: 6-12 months
Reduction in platelet count and spleen size
Time frame: 6-12 months
Reduction of incidence phlebotomies.
Time frame: 6-12 months
Symptoms improvement in patients.
Time frame: 6-12 months
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 8 Oct 2014.
Related trials for Polycythemia Vera
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
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)
Polycythemia Vera (PV)
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.
Enrica Morra, MD study director
Divisione di Ematologia - Ospedale Niguarda Ca' Granda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib Mesylate in people with Polycythemia Vera, run by Niguarda Hospital.
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 3 inclusion and 6 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 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction of Haematocrit to less than 45%. (time frame: 6-12 months). 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 8 Oct 2014.