Clinical trial · Observational
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
NCT01464411CI-TRIAL-00005720D-FirstunknownClinicalTrials.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 effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.
Conditions
Conditions (2)
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, Myelogenous, Chronic, BCR-ABL Positive | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelogenous Leukemia, Chronic, Chronic Phase | Myeloid Leukemia | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of complete molecular response (CMR) after treatment with dasatinib
- timeFrame
- by 18 months
- description
- The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib.
Secondary outcomes (6)
- measure
- complete molecular response (CMR)
- timeFrame
- by 3,6,12,24, 36 months
- measure
- Major Molecular Response(MMR)
- timeFrame
- by 3,6,12,18,24,36 months
- measure
- Complete Cytogenetic Response(CCyR)
- timeFrame
- by 6,12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Months
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase * 20 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 * The case of Pleural effusion clearly * Patients with complications or a history of severe or uncontrolled cardiovascular failure following * have a Myocardial infarction whithin 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 (2)
- DERIVEDIriyama N, Fujisawa S, Yoshida C, Wakita H, Chiba S, Okamoto S, Kawakami K, Takezako N, Kumagai T, Inokuchi K, Ohyashiki K, Taguchi J, Yano S, Igarashi T, Kouzai Y, Morita S, Sakamoto J, Sakamaki H. Early cytotoxic lymphocyte expansion contributes to a deep molecular response to dasatinib in patients with newly diagnosed chronic myeloid leukemia in the chronic phase: results of the D-first study. Am J Hematol. 2015 Sep;90(9):819-24. doi: 10.1002/ajh.24096. PMID 26103598
- DERIVEDIriyama N, Fujisawa S, Yoshida C, Wakita H, Chiba S, Okamoto S, Kawakami K, Takezako N, Kumagai T, Inokuchi K, Ohyashiki K, Taguchi J, Yano S, Igarashi T, Kouzai Y, Morita S, Sakamoto J, Sakamaki H. Shorter halving time of BCR-ABL1 transcripts is a novel predictor for achievement of molecular responses in newly diagnosed chronic-phase chronic myeloid leukemia treated with dasatinib: Results of the D-first study of Kanto CML study group. Am J Hematol. 2015 Apr;90(4):282-7. doi: 10.1002/ajh.23923. Epub 2015 Mar 2. PMID 25530131