Clinical trial · Interventional
Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP
Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)
NCT04155411CI-TRIAL-00059922unknownPhase 4ClinicalTrials.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 explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCR-ABL | — | UNRESOLVED | — |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Dasatinib | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib 70 mg
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
- timeFrame
- 12 months
- description
- Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
Secondary outcomes (4)
- measure
- Proportion of patients with MR 4.0 at 12 months.
- timeFrame
- 12 months
- description
- Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months. * ECOG performance of 0-2. * Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN. * Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital Exclusion Criteria: * History of any TKI treatments. * History of Pulmonary arterial hypertension and Pleural effusion * NYHA cardiac class 3-4 heart disease. * Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist: * Uncontrolled angina within 12 months. * Diagnosed or suspected congenital long QT syndrome. * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes). * Prolonged QTc interval on pre-entry electrocardiogram (\>450 msec). * Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders. * Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized. * Pregnant or breast-feeding women are excluded. * Patients in late chronic phase (i.e. time from diagnosis to treatment \>12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.