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

Primary Purpose

Acute Myeloid Leukemia, Induction Chemotherapy

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Decitabine, HAAG, AML

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decitabine combined with HAAG Regimen

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2019
Last Updated
September 8, 2019
Sponsor
The First Affiliated Hospital of Soochow University
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, The Second People's Hospital of Huai'an, The Third People's Hospital of Kunshan
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1. Study Identification

Unique Protocol Identification Number
NCT04083911
Brief Title
Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
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, The Second People's Hospital of Huai'an, The Third People's Hospital of Kunshan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Induction Chemotherapy
Keywords
Decitabine, HAAG, AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decitabine combined with HAAG Regimen
Arm Type
Experimental
Arm Description
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in elderly newly diagnosed AML patients.
Intervention Type
Drug
Intervention Name(s)
Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF
Intervention Description
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;
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Day 28-35 of induction course
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
time from randomization to death from any cause
Time Frame
3 years
Title
Leukemia-free survival (LFS)
Description
time from randomization to the first relapse or death
Time Frame
3 years
Title
Cumulative incidence of relapse (CIR)
Description
time from achievement of a remission to the first relapse
Time Frame
3 years
Title
Number of adverse events
Description
adverse events are evaluated with CTCAE V5.0.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia. 60-79 years old. ECOG score: 0-3. No history of previous chemotherapy or target therapy. Provide informed consent. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, Ph.D.
Phone
(0086)51267780086
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Depei Wu, Ph.D.
Phone
(0086)51267780086
Email
wudepei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D.
Phone
(0086)51267780086
Email
xwtang1020@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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