Clinical trial · Interventional
Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
NCT03239886CI-TRIAL-00032215unknownN/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)
This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib discontinuation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Discontinuation
- description
- All subjects will discontinue imatinib
- interventionNames
- Other: imatinib discontinuation
Primary outcomes (1)
- measure
- Number of subjects that remain with RM3log after imatinib discontinuation
- timeFrame
- 24 months
- description
- Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.
Secondary outcomes (3)
- measure
- Number of subjects that recover MR3log after imatinib reintroduction
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria * Treatment with imatinib for at least 36 months * BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months Exclusion Criteria: * Previous allogeneic stem cell transplantation * Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib * Imatinib dose escalation at any time, due to loss or inadequate response * BCR-ABL mutation IS: International Scale MR4log: molecular response of 4log or \<0,1% (IS)
References
Publications (1)
- DERIVEDSeguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, Rocha V, Bendit I. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021 Feb;101:106516. doi: 10.1016/j.leukres.2021.106516. Epub 2021 Jan 21. PMID 33517185