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

A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Elderly Newly Diagnosed Acute Myeloid Leukemia Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia; Induction Chemotherapy
• Intervention / Treatment: Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF

Detailed Description

This is a phase 3, open Label, single arm, multi-center study in elderly newly diagnosed AML patients. The patients will receive DAC combined with HAAG in the induction treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Depei Wu, Ph.D.; Phone Number: (0086)51267780086; Email: wudepei@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
2. 60-79 years old.
3. ECOG score: 0-3.
4. No history of previous chemotherapy or target therapy.
5. Provide informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Decitabine combined with HAAG Regimen; 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; 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	time from randomization to death from any cause	3 years
Number of adverse events	adverse events are evaluated with CTCAE V5.0.	2 years
Leukemia-free survival (LFS)	time from randomization to the first relapse or death	3 years
Cumulative incidence of relapse (CIR)	time from achievement of a remission to the first relapse	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): May 31, 2021
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: September 8, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 8, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Decitabine, HAAG, AML
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Protein Synthesis Inhibitors; Antibiotics, Antineoplastic; Decitabine; Cytarabine; Homoharringtonine; Aclarubicin
• Other Study ID Numbers: DAC-HAAG-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No