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Status unknownNCT03453255Updated Mar 5, 2018

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

A Phase 1/2 interventional study of Chemotherapy in Chemotherapy, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
14 Years to 65 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Chemotherapy

Keywords

  • AML, chidamide, decitabine
03

Who can participate

Ages eligible
14 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    t(8;21)AML

    chemotherapy 5-Aza-2'-deoxycytidine IV 20mg/m2 d8-12 homoharringtonine IV 2mg d1-5 chidamide P.O. 30mg twice/W cytarabine IV 1000mg/m2(\<60 year old) 500mg/m2(\>60 year old) IV q12h d1,3,5

    Drug: Chemotherapy

Interventions

  • DrugChemotherapy

    chidamide, decitabine, homoharringtonine, cytarabine

    Also known as: DCHA

05

What researchers measure

Primary outcomes

  1. Progression free survival

    To evaluate the disease progression free survival of DCHA as postremission therapy for acute myeloid leukemia with t(8;21) . Progression free survival (PFS)- defined as the time from remission for the first time to the first documented disease progression.

    Time frame: 2 years

Secondary outcomes

  1. Overall survival

    Overall survival (OS)- defined as the length of time from trial treatment to death.

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, 100853, China
    • Li Yu, M.D. Ph.D. · Contact · chunhuiliyu@yahoo.com · 86-010-55499003
    • Li Yu, M.D. Ph.D. · Principal investigator
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 16, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03453255
Lead sponsor
Chinese PLA General Hospital
Responsible party
Li Yu (MD. PH.D, Chinese PLA General Hospital) — Principal investigator
First posted
Mar 5, 2018
Start date
Jan 1, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 5, 2018

Study contacts

Li-Xin Wang, MD. Ph.D.
Contact
wanglixin1991@sohu.com
010-66957676
Li Yu, MD. Ph.D.
Contact
chunhuiliy@yahoo.com
010-66957678
Li Yu, MD. Ph.D
principal investigator · Chinese PLA General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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