Clinical trial · Interventional
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
NCT01627132CI-TRIAL-00007253unknownPhase 2ClinicalTrials.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 purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dasatinib
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
- timeFrame
- at 12 months
Secondary outcomes (1)
- measure
- Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
- timeFrame
- at 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic Myeloid Leukemia in the Chronic Phase. * Patients with BCR-ABL-negative checks. * 15 years old over. * ECOG performance status (PS) score 0-2. * Adequate organ function (hepatic, renal and lung). * Signed written informed consent. Exclusion Criteria: * A case with the double cancer of the activity. * Women who are pregnant or breastfeeding. * Patients with complications or a history of severe. * Patients with mutation of T315I、F317L、V299L. * Patients with additional chromosome abnormalities. * The case of Pleural effusion with poor control. * Patients with a history of hematopoietic stem cell transplantation.
References
Publications (1)
- DERIVEDKumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26. PMID 32614159