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Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients

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ClinicalTrials.gov Identifier: NCT04087967
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Second Affiliated Hospital of Soochow University
Changzhou No.2 People's Hospital
The First People's Hospital of Lianyungang
Jingjiang People's Hospital
Zhangjiagang First People's Hospital
Huai'an Second People's Hospital
The Third People's Hospital of Kunshan
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

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 younger than 60 years.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Induction Chemotherapy Drug: Decitabine plus HAAG regimen Drug: Idarubicine plus Cytarabine regimen Phase 3

Detailed Description:
This is a phase 3, randomized, controlled, multi-center study in newly diagnosed AML patients younger than 60. The patients will be randomized to receive either DAC combined with HAAG or IA regimen in the induction treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed Acute Myeloid Leukemia Patients Younger Than 60 Years
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022


Arm Intervention/treatment
Experimental: Decitabine combined with HAAG
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
Drug: Decitabine plus HAAG regimen

Decitabine:20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine:1mg/d,d3~16,intravenous infusion; Aclarubicin:10mg/d, d3~d10, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-16, subcutaneous injection;

Granulocyte colony-stimulating factor (G-CSF):

50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection;


Active Comparator: IA Regimen
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
Drug: Idarubicine plus Cytarabine regimen
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Day 28-35 of induction course ]
    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.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 3 years ]
    time from randomization to death from any cause

  2. Leukemia-free survival (LFS) [ Time Frame: 3 years ]
    time from randomization to the first relapse or death

  3. Cumulative incidence of relapse(CIR) [ Time Frame: 3 years ]
    time from achievement of a remmission to the first relapse

  4. Number of adverse events [ Time Frame: 2 years ]
    adverse events are evaluated with CTCAE V5.0.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
  2. Age 18-59.
  3. ECOG score: 0-2.
  4. Treatment related or secondary AML.
  5. No history of previous chemotherapy or target therapy.
  6. Provide informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087967


Contacts
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Contact: Xiaowen Tang, Ph.D. (0086)51267780086 xwtang1020@163.com
Contact: Depei Wu, Ph.D. (0086)51267780086 drwudepei@163.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Xiaowen Tang, Ph.D.    (0086)51267780086    xwtang1020@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Second Affiliated Hospital of Soochow University
Changzhou No.2 People's Hospital
The First People's Hospital of Lianyungang
Jingjiang People's Hospital
Zhangjiagang First People's Hospital
Huai'an Second People's Hospital
The Third People's Hospital of Kunshan
Investigators
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Principal Investigator: Xiaowen Tang, Ph.D. The First Affiliated Hospital of Soochow University

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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT04087967     History of Changes
Other Study ID Numbers: DAC-HAAG-01
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Soochow University:
Decitabine
HAAG
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors