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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087967
• Other study ID #: DAC-HAAG-01
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2019
• Source: The First Affiliated Hospital of Soochow University
• Contact: Xiaowen Tang, Ph.D.
• Phone: (0086)51267780086
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Induction Chemotherapy
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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;
• Idarubicine plus Cytarabine regimen
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (8)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Changzhou No.2 People's Hospital, Huai'an Second People's Hospital, Jingjiang People's Hospital, Second Affiliated Hospital of Soochow University, The First People's Hospital of Lianyungang, The Third People's Hospital of Kunshan, Zhangjiagang First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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