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

NCT03453255 | Unknown Phase 1

• 1 other identifier: 301-XYK-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy

Keywords

AML, chidamide, decitabine

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• Overall survival

  2 years

Study Arms (1)

t(8;21)AML

EXPERIMENTAL

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

Chemotherapy DRUG

chidamide, decitabine, homoharringtonine, cytarabine

Also known as: DCHA

t(8;21)AML

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Li Yu, MD. Ph.D

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Xin Wang, MD. Ph.D.

CONTACT

010-66957676; wanglixin1991@sohu.com

Li Yu, MD. Ph.D.

CONTACT

010-66957678; chunhuiliy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PH.D

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 5, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)