Clinical trial · Interventional
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS
NCT01887561CI-TRIAL-00011146unknownPhase 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 |
|---|---|---|---|
| Myelogenous Leukemia, Chronic, Chronic Phase | Myeloid Leukemia | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- treatment
- interventionNames
- Drug: dasatinib
Primary outcomes (1)
- measure
- The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
- timeFrame
- by 12 months
Secondary outcomes (8)
- measure
- 'Dasatinib affects immunological responses, as measured by flow cytometry
- timeFrame
- at 3,6,12,24 months
- measure
- Major Molecular Response(MMR) rate measured by RQ-PCR
- timeFrame
- by 1 months, then every 6 months for 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase * 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. * female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period * Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline * A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
References
Publications (0)
Data not yet available
No reference posted for this study.