Clinical trial NCT03453255: DCHA as Postremission Therapy for AML With t(8;21)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chemotherapy
Keywords: AML, chidamide, decitabine
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* • Written informed consent provided.

  * The patients were diagnosed AML-M2 with t(8;21) (q22;q22) chromosomal changes and positive acute myeloid leukemia(AML1)-eight twenty one(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.
  * Eastern Cooperative Oncology Group（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 Q and T interval（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.

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Li Yu, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: