Clinical trial · Interventional
Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
- 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)
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials. Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.
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 Leukaemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib stop | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- interventionNames
- Drug: Imatinib stop
Primary outcomes (1)
- measure
- Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript.
- timeFrame
- Every months during two years
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- after two years
- description
- Number of patients alive or died will be measured
- measure
- Clinical and biological profile of patient with complete molecular remission persistence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years and older. * Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years. * Complete molecular remission under treatment with imatinib for at least 2 years. * HIV serology negative and absence of chronic hepatitis B or C. * Molecular monitoring according to the international recommendations before the beginning of the study * For the women old enough to procreate, method of effective contraception * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: * Under 18 years old. * Pregnant at the inclusion's time. * Hospitalized patients without consent. * Adults under law protection or without ability to assent. * Previous or planned allogeneic stem cell transplantation. * HIV serology positive or chronic hepatitis B or C. * Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).
References
Publications (1)
- RESULTAlcazer V, Dulucq S, Mosnier I, Chabane K, Bertin-Mourot P, Derruau S, Balsat M, Labussiere-Wallet H, Sujobert P, Mahon FX, Etienne G, Nicolini F, Hayette S. Development and External Validation of a Transcriptome-Based Multivariable Prediction Model for Treatment-Free Remission in Chronic Myeloid Leukemia. J Clin Oncol. 2026 Jul 20;44(21):1992-2005. doi: 10.1200/JCO-25-02948. Epub 2026 Jun 9. PMID 42454992