Status:
UNKNOWN
DCHA as Postremission Therapy for AML With t(8;21)
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Chemotherapy
Eligibility:
All Genders
14-65 years
Phase:
PHASE1
PHASE2
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 t...
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...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03453255
Start Date
January 1 2018
End Date
December 31 2020
Last Update
March 5 2018
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, China, 100853