NCT03453255

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

Decitabine in Combination With Chidamide, Homoharringtonine and Ara-c (DCHA) as Postremission Therapy for Acute Myeloid Leukemia With t(8;21) :A Multicenter Prospective Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment regimen HA: homoharringtonine 2mg IV d1-5 cytarabine( Ara-C) 1500mg/m2(\<60 year old) ; 1000mg/m2(\>60 year old) IV q12h DCHA: Decitabine 20mg/m2 d8-12 Chidamide 30mg twice/week P.O. for two weeks per cycle (four doses totally) cytarabine( Ara-C) 1500mg/m2(\<60 year old) ; 1000mg/m2(\>60 year old) IV q12h d1,3,5 homoharringtonine 2mg IV d10-14

Conditions

• Chemotherapy

Interventions

Type	Name	Description
DRUG	Chemotherapy	chidamide, decitabine, homoharringtonine, cytarabine

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2018-03-05
• Last updated: 2018-03-05

Locations

1 site across 1 country: China