Clinical trial · Interventional
AFR10 - Combination Therapy of Imatinib Mesylate (IM) + Alpha-2A Interferon for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy 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
Summary
Brief summary (as posted)
Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib mesylate 600mg/day | Drug | Imatinib | ALIAS |
| Peg-Interféron at 90 microg/week | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
Secondary outcomes (1)
- measure
- Evaluate the tolerance of a combination of STI571 and alpha-interferon
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM. * Lack of major cytogenetic response after at least one year of STI 571 as single therapy. * Male and female \* 18 years old. * Informed consent signed up. * Performance status grade 0 - 2 (ECOG). * SGOT and SGPT \<3N * Serum bilirubin \< 1.5 N * Serum creatinine \< 1.5 N * No HSC graft planned * B-HCG negative for female with potential childbearing Exclusion Criteria: * Absence of complete hematologic response * Extramedullar involvement * Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week * Depressive syndrome not controlled * Not controlled dysthyroidy * Auto-immune pathology not controlled * Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study * Significant cardiac disease (grade 3 or more) * Known seropositivity for HIV * Active viral hepatitis * Other malignant disease * Other experimental medication
References
Publications (0)
Data not yet available