Clinical trial · Interventional
Effects of Imatinib Mesylate in Polycythemia Vera
Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
NCT00430066CI-TRIAL-00015808completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib Mesylate
- description
- 400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
- interventionNames
- Drug: Imatinib Mesylate
Primary outcomes (1)
- measure
- Reduction of Haematocrit to less than 45%.
- timeFrame
- 6-12 months
Secondary outcomes (5)
- measure
- Response duration
- timeFrame
- 6-12 months
- measure
- Safety profile
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea * Age \>18 years * Signed written informed consent form Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.