Phase II Study of Safety and Efficacy. Dasatinib in Patients with Chronic Phase Chronic Myelogenous Leukemia achieving a Major Molecular Response on Imatinib.

Phase II Study of Safety and Efficacy. Dasatinib in Patients with Chronic Phase Chronic Myelogenous Leukemia achieving a Major Molecular Response on Imatinib. - Dasatinib CMR-trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007413

Enrollment

Registered

2012-03-01

Start date

2012-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic phase chronic myelogenous leukemia

Interventions

In accordance with the approved dosage and administration of dasatinib for patients with CML-CP resistant to imatinib, 2 X 50 mg tablets of dasatinib are taken once daily (100 mg/day) for 2 years

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)chronic-phase chronic myelogenous leukemia 2)Age 20 years or older 3) Patients for major molecular response (MMR) with no CMR on imatinib. 4) ECOG performance status of 0-2. 5) Adequate organ function (hepatic, renal and lung) 6)Written informed consent from the subject

Exclusion criteria

Exclusion criteria: 1)Active double cancer 2)Pregnant or breastfeeding woman 3)Patient who has clear pleural effusion 4)Patient who have the anamnesis or complications of a cardiovascular disorder with serious or poor control. -myocardial infarction within 6 months -angina pectoris within 3 months -congestive heart failure within 3 months -congenital long QT syndrome

Design outcomes

Primary

Measure	Time frame
The cumulative CMR rate by 18 months after dasatinib treatment	—

Secondary

Measure	Time frame
Cumulative CMR rate by 12 months and 24 months after the initiation of dasatinib treatment Dose intensity in 12 months, a large granular lymphocyte: LGL incidence * Relevance of progression free survival: PFS, safety, Sokal score, and OS, PFS and EFS.	—

Countries

Japan

Contacts

Public ContactToshihiro Miyamoto

Graduate School of Medical Sciences, Kyushu University Department of Medicine and Biosystemic Science

toshmiya@intmed1.med.kyushu-u.ac.jp092-642-5225

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026