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

Phase 3

• Conditions: Induction Chemotherapy; Acute Myeloid Leukemia
• Interventions: Drug: Decitabine plus HAAG regimen; Drug: Idarubicine plus Cytarabine regimen

• Registration Number: NCT04087967
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Study First Posted: 2019-09-12
• Last Update Posted: 2019-09-12
• Primary Completion: 2021-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decitabine combined with HAAG	Decitabine plus HAAG regimen	This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
IA Regimen	Idarubicine plus Cytarabine regimen	This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	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

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China