Intensive chemotherapy with or without Dasatinib in patients with newly diagnosed core binding factor acute myeloid leukemia

A Multicenter Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib in patients with newly diagnosed core binding factor acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15006862

Enrollment

Unknown

Registered

2015-08-02

Start date

2015-09-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Acute myeloid leukemia

Interventions

control group:conventional intensive chemotherapy+placebo

Study gruop:conventional intensive chemotherapy+Dasatinib

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Core-binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or of CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) ; 2. Rule out MDS history and secondary AML; 3. To be aged 18~60 years; 4. Liver and renal function: serum bilirubin<=35umol/L, AST/ALT lower than 2* upper normal serum level, creatinine<=150umol/L; 5. Normal cardiac function: NYHA I/II; 6. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 7. No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diagnostic screening phase; 8. Non-pregnant and non-nursing; 9. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test to rule out pregnancy; 10. Women of child-bearing potential must either commit to take birth control measures at least four weeks before she begins dasatinib therapy; 11. Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking dasatinib and for 3 months after therapy is stopped; 12. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous MDS history, treatment related AML; 2. Previously treated patients; 3. Allergy to any medication in the regimen; 4. Liver and renal insufficiency (beyond the inclusion criteria); 5. Patients with ejection fraction 2); 6. Patients with a "currently active" second malignancy; 7. Patients with "currently active" tuberculosis. Patients with HIV;active HBV, HCV, or Hepatitis A infection; 8. Patients with other hematological disease (including disturbance of blood coagulation not caused by AML); 9. Patients who can't understand or obey the protocol; 10. atients participated in other clinical trial; 11. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

Measure	Time frame
Event Free Survival;Overall Survival;Complete Remission Rate;	—

Secondary

Measure	Time frame
Early Death Rate;Toxicity and Safety;	—

Countries

China

Contacts

Public ContactJunmin Li

lijunmin@medmail.com.cn+86 021-64370045-665258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026