- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087967
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
September 10, 2019 updated by: The First Affiliated Hospital of Soochow University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
162
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Depei Wu, Ph.D.
- Phone Number: (0086)51267780086
- Email: drwudepei@163.com
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Recruiting
- The First Affiliated Hospital of Soochow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
- Age 18-59.
- ECOG score: 0-2.
- Treatment related or secondary AML.
- No history of previous chemotherapy or target therapy.
- Provide informed consent.
Exclusion Criteria:
- Patients are pregnant or lactating.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 28-35 of induction course
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 3 years
|
time from randomization to death from any cause
|
3 years
|
Number of adverse events
Time Frame: 2 years
|
adverse events are evaluated with CTCAE V5.0.
|
2 years
|
Leukemia-free survival (LFS)
Time Frame: 3 years
|
time from randomization to the first relapse or death
|
3 years
|
Cumulative incidence of relapse(CIR)
Time Frame: 3 years
|
time from achievement of a remmission to the first relapse
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 10, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
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
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Decitabine
- Cytarabine
- Idarubicin
Other Study ID Numbers
- DAC-HAAG-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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