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
Phase: PHASE1
Conditions: Chemotherapy
Sponsor: Chinese PLA General Hospital

Decitabine in combination with chidamide, cytarabine and 
homoharringtonine(DCHA)  as postremission therapy for 
acute myeloid leukemia with t(8;21) :A multicenter 
prospective study 
 
 
Sponsor:  Chinese PLA General Hospital 
 
NCT ID not yet assigned 
 
 
 
 
 
 
 
 
 
Document Date:  February 16, 2018 
 
 
 

 
 Purpose 
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 
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 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. We will investigate the 
safety and efficacy of a combination regimen including 
decitabine, chidamide, cytarabine and homoharringtonine as 
the postremission therapy for AML with t(8;21). 
Primary Outcome Measure: 
Progression free survival   [Time Frame: 2 years] 
Secondary Outcome Measures: 
Overall survival   [Time Frame: 2 years] 

 
Estimated Enrollment: 120  
Study Start Date: January 1, 2017  
Estimated Study Completion Date: December 31, 2019  
Estimated Primary Completion Date: December 31, 2018  
 
 
Eligibility 
Ages Eligible for Study: 14 Years to 65 Years 
Sexes Eligible for Study: All 
Gender Based: 
No 
Inclusion Criteria: 
Written informed consent provided. 
     The patients were diagnosed AML-M2 with t(8;21) 
(q22;q22) chromosomal changes and positive AML1-ETO 
fusion gene according to the 2008 World Health Organization 
(WHO) diagnostic criteria for malignant myeloid diseases. 
     Males or females aged ≥18 years, < 65 years. 
      ECOG performance status 0-3. 
      Life expectancy ≥3 months. 
      The morphology was Complete remission (CR) or Cri 
after 2 cycles of anthracycline induced chemotherapy. 

      No serious disease with heart, lung, liver and kidney. 
      The ability to understand and be willing to sign the 
Informed Consent Form of the experiment. 
       Patient who can start the investigational therapy 
within 3-6 weeks after the complete resection 
       Adequate liver function: Total bilirubin ≤ 1.5 x upper 
limit of normal (ULN), Aspartate aminotransferase (AST), 
alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects 
without liver metastases; ≤ 5 x ULN in subjects with liver 
metastases. 
       Adequate renal function: Serum creatinine ≤ 1.25 x 
ULN, or ≥ 60 ml/min. 
        Female 
subjects 
should 
not 
be 
pregnant 
or 
breast-feeding. 
Exclusion Criteria: 
Known allergic to prior treatment with drugs contained 
by the trial programme or with a chemical structure 
similar medicine. 
Pregnancy, breast-feeding women and childbearing age 
patients who do not want to take contraceptive 
measures. 
Active serious infection. 

Patients with extramedullary lesions. 
Patients who use drugs or drink alcohol for a long time 
to influence the evaluation of results. 
Patients with mental illness or other conditions are 
unable to obtain knowledge and consent, and can not 
cooperate with the requirements of the completion of 
the test treatment and examination steps. 
Patients with a history of the clinical significance of QTc 
prolongation (male > 450ms, female >470ms), 
ventricular tachycardia (VT), atrial fibrillation (AF), 
degree of heart block, muscle infarction (MI) within 1 
years, congestive heart failure (CHF), with symptoms 
and drug therapy in patients with coronary heart 
disease. 
Patients with abnormal liver function (total bilirubin > 
1.5 x ULN, ALT/AST > 2.5 x ULN, or liver invasion 
ALT/AST > 5x ULN ), renal function abnormality 
(serum creatinine > 1.5 x ULN). 
The 
researchers 
decided 
that 
patient 
was 
not 
appropriate to take part in the experiment. 
 
 

 
Treatment regimen 
HA: 
homoharringtonine  2mg   IV   d1-5 
cytarabine( 
Ara-C) 
 
1500mg/m2(<60 
year 
old) 
; 
1000mg/m2(>60 year old) 
IV q12h  d1,3,5 
 
 
 
 
 
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 
 

 
Process schedule 
 
 
 
Statistical analysis  
SAS 9.0 software (SAS Institute) will be used in all statistical 

analysis. Survival data were analyzed by the log-rank test, 
and survival curves will be plotted with the Kaplan-Meier 
method. t test will be used to assess the probability of 
significant differences of survival time. P < 0.05 was 
considered statistically significant.