Clinical trial · Interventional
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
NCT00478985CI-TRIAL-00011177STIMcompletedN/AClinicalTrials.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 first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.
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 |
|---|---|---|---|
| Myeloid Leukemia, Chronic | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib ending | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Imatinib treatment ending
- interventionNames
- Behavioral: Imatinib ending
Primary outcomes (1)
- measure
- Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
- timeFrame
- Every month during the first year and every two months during the second year
Secondary outcomes (4)
- measure
- T lymphocytes differenciation and proliferation analyse / cytokines production analyse
- timeFrame
- first visit, M2,M4,M6,M9,M12,M18,M24
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have reached their 18th birthday * Women of childbearing potential must agree to use effective methods of contraception * Patients must be affiliated to a social security regime * Patients must have received imatinib therapy for at least 36 months. * Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts. * Patients must be HIV, HCV and HBV negatives * Patients who have molecular follow-up realized in accordance with international recommendations * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: * Patients who are protected by the law. Patients who are unable to give their consent to participate to the study. * Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α): Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe
References
Publications (3)
- DERIVEDMahon FX, Dulucq S, Rea D, Nicolini FE, Rigal-Huguet F, Machova Polakova K, Dubruille V, Noel MP, Ianotto JC, Villemagne B, Cayssials E, Park S, Rousselot P, Etienne G. Extended long-term follow-up and the survival of Stop Imatinib study. Blood Neoplasia. 2025 Oct 27;3(1):100177. doi: 10.1016/j.bneo.2025.100177. eCollection 2026 Feb. PMID 41574312
- DERIVEDRea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18. PMID 28522576
- DERIVEDMahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19. PMID 20965785