Phase II clinical trial of low dose dasatinib in patients with resistant or intolerant chronic myeloid leukemia who are treated with low lose imatinib

Phase II clinical trial of low dose dasatinib in patients with resistant or intolerant chronic myeloid leukemia who are treated with low lose imatinib - A study of low dose dasatinib in patients with resistant or intolerant CML who are treated with low lose imatinib

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003499

Enrollment

Registered

2010-04-20

Start date

2010-04-01

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 patients in chronic phase who are refractory or resistant to low dose imatinib therapy.

Interventions

Patients initially receive 50 mg of dasatinib, and then the dose will be up to 100mg.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Signed Written Informed Consent Subjects with chronic phase chronic myeloid leukemia (CML) Subjects resistant/intolerant to imatinib less or equal than 200mg 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The ratio of patients who achieved major molecular response (MMR) after 12 months of dasatinib therapy.	—

Countries

Japan

Contacts

Public ContactKazuteru Ohashi

Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan. Hematology Division

Outcome results

None listed

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