Phase II clinial trial of Dasatinib for Imatinib resistant or refractory chronic myeloid leukemia in chronic phase.

Phase II clinial trial of Dasatinib for Imatinib resistant or refractory chronic myeloid leukemia in chronic phase. - Phase II trial of Dasatinib for Imatinib resistant/refractory CML in CP.

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002779

Enrollment

120

Registered

2009-12-01

Start date

2009-04-01

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 Imatinib therapy.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: @ECOG performance status 0~2. @Normal organ (liver, kidney, lung) function as indicated as follows; AST or ALT < 5xULN T.Bil < 3xULN cre < 3xULN Neutrophil counts >=1,000/microL Platelet counts >= 50,000/mm3 Body temperature < 37.5 degrees PaO2>=60mmHg or SpO2>=93% (room air) @Able to obtain written informed consent for the trial.

Exclusion criteria

Exclusion criteria: Patients who are true with either of the followings are excluded; @Females in childbearing years with no will or capability to use appropriate birth control during the trial. @Females during pregnancy or lactation. @Male patients with no will or capability to use appropriate birth control during the trial. @Past history or concomitant cardiovascular diseases that are serious or poorly-controlled. @Other serious past disease history or present concomitant diseases that are considered inappropriate to condcut this trial. @Active infectious diseases, or Other malignancies, or HBV/HIV infection. @Pasthistory of Dasatinib therapy.

Design outcomes

Primary

Measure	Time frame
The ratio of patients who achieved complete cytogenetic response (CCyR) after 12 months of Dasatinib therapy.	—

Countries

Japan

Outcome results