drugset / Trial / NCT03453255

DCHA as Postremission Therapy for AML With t(8;21)

NCT03453255

Phase 1/2 Unknown 120 enrolled Chinese PLA General Hospital
NaSingle-groupOpen-labelTreatment

Summary

Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy. Chromosomal translocation with t (8; 21) (q22; q22) , about 10 \~ 15% incidence in AML and 40% incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good prognosis. The National Comprehensive Cancer Network (NCCN) guidelines recommend that high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation chemotherapy and more than 70% recurrence rate with (tyrosine kinase)KIT mutation. So the exploration of a relatively safe and efficient consolidation therapy is one of the difficult problems to be solved in the treatment of mitigatory t (8; 21) AML.

Timeline

Start
2018-01-01
Primary completion
2019-12-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 500 mg/m2 Intravenous
Subject Cytarabine Small molecule 1000 mg/m2 Intravenous
Subject Cytarabine Small molecule 1500 mg/m2 Intravenous
Subject Decitabine Small molecule 20 mg/m2
Subject Homoharringtonine Small molecule 2 mg Intravenous
Subject Tucidinostat Small molecule 30 mg Oral

Indications

No indication recorded.