Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60

NCT04083911 | Unknown Phase 3

• 1 other identifier: DAC-HAAG-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients older than 60 years.

Conditions

Acute Myeloid Leukemia; Induction Chemotherapy

Keywords

Decitabine, HAAG, AML

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR includes complete response (CR), CRi and PR. CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.

  Day 28-35 of induction course

Secondary Outcomes (4)

• Overall survival (OS)

  3 years

• Leukemia-free survival (LFS)

  3 years

• Cumulative incidence of relapse (CIR)

  3 years

• Number of adverse events

  2 years

Study Arms (1)

Decitabine combined with HAAG Regimen

EXPERIMENTAL

This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in elderly newly diagnosed AML patients.

Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF

Interventions

Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF DRUG

Decitabine:20mg/m2/d, d1\~5, intravenous infusion; Homoharringtonine:1mg/d,d3\~9,intravenous infusion; Aclarubicin:10mg/d, d3\~d6, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-9, subcutaneous injection; Granulocyte colony-stimulating factor: 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Decitabine combined with HAAG Regimen

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
• years old.
• ECOG score: 0-3.
• No history of previous chemotherapy or target therapy.
• Provide informed consent.

You may not qualify if:

• Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
• Patients with another malignant disease.
• Patients with uncontrolled active infection.
• Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
• Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
• Patients with creatinine clearance rate \< 50ml/min.
• Patients with active hepatitis B or hepatitis C infection.
• Patients with HIV infection.
• Patients with other commodities that the investigators considered not suitable for the enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Second Affiliated Hospital of Soochow University: collaborator
• Changzhou No.2 People's Hospital: collaborator
• The First People's Hospital of Lianyungang: collaborator
• Jingjiang People's Hospital: collaborator
• Zhangjiagang First People's Hospital: collaborator
• The Second People's Hospital of Huai'an: collaborator
• The Third People's Hospital of Kunshan: collaborator

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Homoharringtonine; Aclarubicin; Cytarabine; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Harringtonines; Alkaloids; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xiaowen Tang, Ph.D.

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Tang, Ph.D.

CONTACT

(0086)51267780086; xwtang1020@163.com

Depei Wu, Ph.D.

CONTACT

(0086)51267780086; wudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 10, 2019
• Study Start: April 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

CN (1)