Clinical trial · Interventional
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
NCT00219752CI-TRIAL-00000253completedPhase 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 aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib mesylate 400 mg | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Tolerability
- measure
- Quality of life
Secondary outcomes (5)
- measure
- . the survival without progression
- measure
- . the survival without event
- measure
- . the overall survival
- measure
- . the hematologic cytogenetic and molecular responses at various check points.
- measure
- . duration of responses and failure to respond
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * CML Ph+ (assessed by cytogenetic or FISH) * Chronic phase with less than 5% bone marrow blasts * Diagnosis within 12 months * Age ≥ 70 year at inclusion * PS grade 0 to 2 (ECOG) * Mini mental status more than 25 * Hydroxyurea optional before Imatinib * Adequate end organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln. Exclusion Criteria: * patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital * Mini mental status ≤ 25 * patients who are not able to adequately take the study drug * Age less than 70 y * accelerated or blastic phase * previous therapy with imatinib or interferon * HIV positivity
References
Publications (0)
Data not yet available
No reference posted for this study.