Phase II clinical trial of dasatinib in newly diagnosed chronic phase chronic myelogenous leukemia

Phase II clinical trial of dasatinib in newly diagnosed chronic phase chronic myelogenous leukemia - Phase II trial of dasatinib for newly diagnosed CP-CML.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006346

Enrollment

Registered

2011-10-01

Start date

2011-10-01

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

newly diagnosed chronic myelogenous leukemia in chronic phase

Interventions

Administer Dasatinib 100mg/day parenterally.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) CP-CML Blast < 15% Blast + promyelocyte < 30% Basophils in peripheral blood <20% Platelet >= 100x10^9/L (2) 20 years old or older (3) ECOG performance status 0~2 (4) Normal organ function(liver, kidney, lung) as indicated as follows; AST and ALT < 1.5xULN or Total bilirubin < 5xULN. Serum creatinine < 1.5xULN. Neutrophil count >=1,000/mcl Platelet >= 50,000/mm3 (5) A hydroxycarbamide use case for the purpose of the blood corpuscle control. (Duration of use is principle less than two weeks.) (6) The patients that is able to obtain written informed consent for the trial.

Exclusion criteria

Exclusion criteria: Patients who are true with either of the followings are excluded; (1) A case with the double cancer of the activity. (2) Females during pregnancy or lactation. (3) Patients with no will or capability to use appropriate birth control during the trial. (4) Other serious past disease history or present concomitant diseases that are considered inappropriate to conduct this trial. (5) Past history of tyrosine kinase inhibitor therapy. (6) The patients of accelerated phase or blast phase clearly. (7) The patients with positive one of HBs antigen, HCV antibody, HIV antibodies

Design outcomes

Primary

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

Secondary

Measure	Time frame
(1) MMR rate at 6 months after the treatment. (2) CMR rate at 12 months after the treatment. (3) CCyR rate (4) The correlation of LGL expression and the MMR rate. (5) The correlation of LGL expression and onset of pleural effusion. (6) The examination of the optimal administration schedule. (7) The frequencies of adverse events Grade3 or more. (8) Event Free Survival(EFS) (9) Overall Survival (OS)	—

Measure

Time frame

(1) MMR rate at 6 months after the treatment. (2) CMR rate at 12 months after the treatment. (3) CCyR rate (4) The correlation of LGL expression and the MMR rate. (5) The correlation of LGL expression and onset of pleural effusion. (6) The examination of the optimal administration schedule. (7) The frequencies of adverse events Grade3 or more. (8) Event Free Survival(EFS) (9) Overall Survival (OS)

—

Countries

Japan

Outcome results

None listed

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