A phase 2 study of mid-term compliance and effectiveness of dasatinib therapy in patients with chronic myeloid leukemia.

A phase 2 study of mid-term compliance and effectiveness of dasatinib therapy in patients with chronic myeloid leukemia. - DARIA 01 Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007345

Enrollment

Registered

2012-03-01

Start date

2012-04-01

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 myeloid leukemia chronic phase

Interventions

Dasatinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. CML-CP 2. Age>15 years old 3. PS 0-2 (ECOG) 4. Adequate hepatic, renal, pulmonary and cardiac function 5. ECG QTc<0.45msec 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant and/or lactating woman 2. Other active neoplasms 3. History of sever bleeding tendency 4. Psychological disorders 5. Recent history of ischemic heart disease

Design outcomes

Primary

Measure	Time frame
Compliance of dasatinib therapy at 12 months for patients with chronic myeloid leukemia.	—

Secondary

Measure	Time frame
Treatment related toxicity (TRT) Relationship between serum concentration of Dasatinib and clinical result (TRT, Complete Cytogenetical remission rate,Major molecular Remission rate,Complete molecular remission) Overall survival rate at 1 year Progression free survival at 1 year	—

Countries

Japan

Contacts

Public ContactShuichi Mizuta

Fujita Health University Department of Hematology

mizuta@mb.ccnw.ne.jp0562-93-9243

Outcome results

None listed

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