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

Sponsor

The First Affiliated Hospital of Soochow University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04083911

Collaborator

Second Affiliated Hospital of Soochow University (Other), Changzhou No.2 People's Hospital (Other), The First People's Hospital of Lianyungang (Other), Jingjiang People's Hospital (Other), Zhangjiagang First People's Hospital (Other), The Second People's Hospital of Huai'an (Other), The Third People's Hospital of Kunshan (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Induction Chemotherapy	Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decitabine combined with HAAG Regimen This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in elderly newly diagnosed AML patients.	Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF 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;

Arm

Intervention/Treatment

Experimental: Decitabine combined with HAAG Regimen

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

Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF

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;

Outcome Measures

Primary Outcome Measures

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

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 remission to the first relapse
Number of adverse events [2 years]
adverse events are evaluated with CTCAE V5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Investigators

Principal Investigator: Xiaowen Tang, Ph.D., The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital of Soochow University

ClinicalTrials.gov Identifier:

NCT04083911

Other Study ID Numbers:

DAC-HAAG-02

First Posted:

Sep 10, 2019

Last Update Posted:

Sep 10, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The First Affiliated Hospital of Soochow University

Decitabine, HAAG, AML

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Sep 10, 2019