Prospective, randomized, single-center, controlled trial for dasatinib maintenance therapy after autologous hematopoietic stem cell transplantation in CBF-AML

Single-center prospective randomized controlled trial for dasatinib maintenance therapy after autologous hematopoietic stem cell transplantation in core-binding factor acute myeloid leukemia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034990

Enrollment

Unknown

Registered

2020-07-26

Start date

2020-07-19

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

core-binding factor acute myeloid leukemia

Interventions

Group A :Dasatinib 100mg po qd

Group B:observation

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) According to the Chinese Guidelines for the Diagnosis and Treatment of adult acute myeloid leukemia (non-acute promyelocytic leukemia) (revised in 2017), the initial diagnosis was accompanied by T (8; 21) (q22; Q22.1), INV (16)(P13.1 Q22) or T (16; 16) (p13.1; Q22) AML patients with chromosomal abnormalities; (2) Male or female aged =3 months; (3) ECOG score 0 to 2; (4) No major organ dysfunction; (5) Subjects or their legal representatives understand and sign the informed consent of chemotherapy before the clinical study begins.

Exclusion criteria

Exclusion criteria: (1) High-risk AML patients; (2) Patients with other systemic malignant tumors; (3) Unstable angina pectoris or New York Heart Association type 3/4 congestive heart failure with multiple organ dysfunction; (4) Patients whose infection cannot be controlled; (5) ECOG score: >2; (6) Uncontrolled restrictive or obstructive pulmonary disease; (7) PATIENTS with HIV seropositivity or hepatitis B and C active stage; (8) Those who have used the experimental drug 4 weeks before the first administration; (9) Those who had received bone marrow or stem cell transplantation within 12 weeks before the first administration; (10) Those who received radiotherapy 2 weeks before the first administration; (11) mental illness that prevents the subject from completing treatment or informed consent; (12) are participating in other clinical trials or are under observation; (13) Pregnant patients (14) Other circumstances deemed inappropriate by the researcher.

Design outcomes

Primary

Measure	Time frame
OS;DFS;	—

Secondary

Measure	Time frame
CR;Overall response rate;Cumulative replase rate;nonreplase mortality;Recurrence rate of CNSL;	—

Countries

China

Contacts

Public ContactXing Hongyun

Department of Hematology, Affiliated Hospital of Southwest Medical University

393064897@qq.com+86 18283035160

Outcome results

None listed

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