Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
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
1 other identifier
interventional
162
1 country
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 younger than 60 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 8, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedSeptember 12, 2019
September 1, 2019
2.2 years
September 8, 2019
September 10, 2019
Conditions
Keywords
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 (2)
Decitabine combined with HAAG
EXPERIMENTALThis cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
IA Regimen
ACTIVE COMPARATORThis cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
Interventions
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;
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Soochow Universitylead
- Second Affiliated Hospital of Soochow Universitycollaborator
- Changzhou No.2 People's Hospitalcollaborator
- The First People's Hospital of Lianyungangcollaborator
- Jingjiang People's Hospitalcollaborator
- Zhangjiagang First People's Hospitalcollaborator
- The Second People's Hospital of Huai'ancollaborator
- The Third People's Hospital of Kunshancollaborator
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaowen Tang, Ph.D.
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2019
First Posted
September 12, 2019
Study Start
April 1, 2019
Primary Completion
May 31, 2021
Study Completion
May 31, 2022
Last Updated
September 12, 2019
Record last verified: 2019-09