Clinical trial · Interventional
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
A Phase II Study to Determine the Activity of Dasatinib Administered Orally (PO) at a Dose of 100 mg Once Daily (QD) in Chronic Phase Chronic Myelogenous Leukemia (CML), at a Dose of 70 mg Twice Daily (BID) in Advanced Phase Chronic Myelogenous Leukemia (CML) Chinese Subjects Who Are Resistant to or Intolerant of Imatinib Mesylate (Gleevec®)
- 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 primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Dasatinib
Primary outcomes (2)
- measure
- Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)
- timeFrame
- From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010)
- description
- Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR) or Partial Cytogenetic Response (PCyR). CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow \[BM\] PCyR: 1-35% Ph-chromosome-positive cells in metaphase in \[BM\].
- measure
- Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
- timeFrame
- From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Signed Written Informed Consent * Men and women, ages 18 years of age or older * Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) * Subjects resistant/intolerant to imatinib * Subjects presenting: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower limit of normal range Exclusion Criteria: * Women of child bearing potential who are not using adequate birth control * Women who are pregnant or breastfeeding * Subjects eligible for stem cell transplantation * Serious uncontrolled medical disorder or active infection * Uncontrolled or significant cardiovascular disease * Concurrent incurable malignancy other than CML * Subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, Dasatinib in the past * History of significant bleeding unrelated to CML
References
Publications (0)
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