Skip to content

A phase II clinical trial for Dasatinib combined with chemotherapy in the treatment of pediatric acute myeloid leukemia (AML) companying C-KIT mutation: an addition of CALS III-AML protocol

Dasatinib combined with chemotherapy in treating pediatric acute myeloid leukemia (AML) combined with C-KIT mutation

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024325
Enrollment
Unknown
Registered
2019-07-06
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Pediatric Acute Myeloid Leukemia

Interventions

Dasatinib combined Group:AML patients with C-KIT mutation received Dasatinib combined treatment.
Historical Control Group:AML patients with C-KIT mutation received Chemotherapy only in historical group before this study.

Sponsors

The Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. de novo pediatric AML with KIT mutations; 2. Patients with CBF AML (RUNX1-RUNX1T1 or CBFB-MYH11) with a single KIT mutation (whether exon 8 or exon 17) are eligible to receive dasatinib combined with chemotherapy and are not candidates for HCT in first remission; 3. Patients with CBF-AML or other AML subtypes with other mutations in addition to KIT mutations are candidates for HCT according to individuals treatment response. Patients undergoing transplantation are candidates for dasatinib after hematopoietic stem cell transplantation.

Exclusion criteria

Exclusion criteria: Pediatric AML patients without C-KIT mutation.

Design outcomes

Primary

MeasureTime frame
Tolerance of Dasatinib with dose of 80mg/m2;Other adverse effect related to Dasatinib;

Secondary

MeasureTime frame
2-year Event Free Survival;5-year EFS;The occurrence of Sever Adverse Event in patients received Dasatinib treatment;

Countries

China

Contacts

Public ContactShaoyan Hu

The Children's Hospital of Soochow University

hsy139@126.com+86 0512-80692936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026