Clinical trial · Interventional
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
NCT00866736CI-TRIAL-00019120completedPhase 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 evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
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
- rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
- timeFrame
- at 12 months
Secondary outcomes (5)
- measure
- safety after treatment with dasatinib
- timeFrame
- 2 year
- measure
- rate of Complete Cytogenetic Response(CCyR)
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Written Informed Consent * Subjects with chronic phase chronic myeloid leukemia (CML) * Subjects resistant/intolerant to imatinib * Subjects presenting: 1. ECOG performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. Adequate lung function Exclusion Criteria: * Concurrent malignancy other than CML * Women who are pregnant or breastfeeding * Concurrent pleural effusion * Uncontrolled or significant cardiovascular disease * A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy. * Prior therapy with dasatinib * Subjects with T315I and/or F317L BCR-ABL point mutations
References
Publications (1)
- DERIVEDInokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204. doi: 10.3960/jslrt.54.197. PMID 25501110