Clinical trial · Interventional
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties of enrolment of Patient
Summary
Brief summary (as posted)
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.
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 |
|---|---|---|---|
| Leukemia, Myeloid, Chronic-Phase | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
| Imatinib Mesylate 400 MG Oral Tablet | Drug | Imatinib | ALIAS |
| Imatinib Mesylate 600 MG Oral Tablet | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Imatinib 600 (Randomized trial)
- description
- Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
- interventionNames
- Drug: Imatinib Mesylate 600 MG Oral Tablet
- type
- ACTIVE_COMPARATOR
- label
- Imatinib 400 (Randomized trial)
- description
- Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
- interventionNames
- Drug: Imatinib Mesylate 400 MG Oral Tablet
- type
- OTHER
- label
- Imatinib400 (Cohort)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d, 2. Patients in complete cytogenetic response for at least 1 year 3. Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR) 4. ECOG ≤ 2, 5. Age ≥ 18 years 6. Signed informed consent, 7. Membership of a social security system Exclusion Criteria: 1. Patients with CML-CP Philadelphia chromosome negative diagnosis. 2. Patients previously treated with Imatinib Mesylate at doses above 400 mg / day 3. Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d 4. Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment 5. Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective 6. Known HIV positive 7. Patients previously treated with another tyrosine kinase inhibitor 8. Patient participating in another interventional clinical trial 9. History of non-compliance to Imatinib Mesylate
References
Publications (0)
Data not yet available