NCT03560908

Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.

Conditions

• Relapsed AML
• T(8;21)
• C-KIT Mutation

Interventions

Type	Name	Description
DRUG	Dasatinib	Dasatinib 70mg twice a day will be administered orally for 2 weeks along with re-induction chemotherapy from day 1 of chemotherapy. Recommended re-induction regimens include (1)FLAG: Fludarabine 30mg/m2/d,d1-5;cytarabine 1g-2g/m2/d,d1-5;±G-CSF;(2)IA/DA:idarubicin 8-12mg/m2/d,d1-3 or daunorubicin 45-60mg/m2/d，d1-3;cytarabine 100-200mg/m2/d，d1-7;(3)CAG:Aclarubicin 20mg/d,d1-4；cytarabine 15mg/m2/Q12h,d1-14; ±G-CSF.The chemotherapy regimen is not limited to recommended regimens. Patients will be recommended to receive allogeneic hematopoietic stem cell transplantation (HSCT) once complete remission is achieved. Otherwise, they will continue the consolidation chemotherapy.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2018-06-18
• Last updated: 2025-05-01

Locations

1 site across 1 country: China