Clinical trial · Interventional
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Enrollment
Summary
Brief summary (as posted)
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- 50-180 mg once daily (QD)
- interventionNames
- Drug: Dasatinib
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- 200-800 mg QD
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Complete Cytogenetic Response (CCyR) Rate at Month 6
- timeFrame
- Month 6
- description
- Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg * Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis * Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 * Adequate hepatic and renal function Exclusion Criteria: * Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant * Previous diagnosis of accelerated/blast crisis CML * Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases * Previous documentation of T315I mutation * Uncontrolled or significant cardiovascular disease * Serious uncontrolled medical disorder/active infection * History of significant bleeding disorder unrelated to CML * Intolerance to imatinib ≥400 mg * Concurrent malignancies other than CML
References
Publications (0)
Data not yet available