Clinical trial · Interventional
Treatment of Polycythemia Vera With Gleevec
A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
NCT01120821CI-TRIAL-00003455completedPhase 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 research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.
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 |
|---|---|---|---|
| Gleevec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study drug
- description
- Gleevec treatment
- interventionNames
- Drug: Gleevec
Primary outcomes (2)
- measure
- Stabilization of hematocrit
- timeFrame
- Weekly for the first six week of treatment, then monthly for one year from study entry.
- measure
- Platelet count maintenance a therapeutic range.
- timeFrame
- Weekly for the first six weeks of treatment, then monthly for one year from study entry.
Secondary outcomes (2)
- measure
- Splenomegaly (if existent)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. total bilirubin \<1.5 x upper limit of the normal range (ULN) 2. SGOT (AST) and SGPT (ALT) \< 2.5 x ULN 3. creatinine \< 1.5 x ULN 4. ANC \> 1.5 x 109/L * Written voluntary informed consent. Exclusion Criteria: * 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. * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.