Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML

NCT05264883 | Unknown Phase 3

• 1 other identifier: 2021-SR-278
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia. This study involves the following: Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi)

  CR is defined as absolute neutrophil count \> 10\^9/ L, platelets \> 100×10\^9/L, red cell transfusion independence, and bone marrow with \< 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of \< 10\^9/L or platelets \< 100×10\^9/L.

  From randomization to the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (7)

• Partial Remission (PR) Rate

  From randomization to the end of Cycle 1 (each cycle is 28 days)

• Overall Response Rate (ORR)

  From randomization to the end of Cycle 1 (each cycle is 28 days)

• Rate of Minimal Residual Disease (MRD) negativity

  From randomization to the end of Cycle 1 (each cycle is 28 days)

• Overall survival (OS)

  From the time of randomization to time for up to 2 years

• Disease-Free Survival (DFS)

  From the time of randomization to time for up to 2 years

Study Arms (2)

Venetoclax combined with Decitabine/Azacitidine and Aclarubicin

EXPERIMENTAL

Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) Aclarubicin (Acla): 10mg/m2 intravenous daily (d1 to d3);

Drug: Venetoclax-Decitabine/Azacitidine-Aclarubicin Association

Venetoclax combined with Decitabine/Azacitidine

ACTIVE COMPARATOR

Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes)

Drug: Venetoclax-Decitabine/Azacitidine Association

Interventions

Venetoclax-Decitabine/Azacitidine-Aclarubicin Association DRUG

Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin

Venetoclax combined with Decitabine/Azacitidine and Aclarubicin

Venetoclax-Decitabine/Azacitidine Association DRUG

Treatment with Venetoclax+Decitabine/Azacitidine

Venetoclax combined with Decitabine/Azacitidine

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute myeloid leukemia (AML) diagnosed by bone marrow morphology and immunophenotyping (in line with WHO 2016 diagnostic criteria);
• No previous anti-acute leukemia treatment (including demethylating drugs), except hydroxyurea and Leukocyte apheresis;
• Exclude acute promyelocytic leukemia (APL) at the bone marrow morphology or molecular level;
• Age 60-80 years old;
• Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP)≤ 3×upper limit of normal (ULN), serum bilirubin≤ 1.5×ULN; serum creatinine≤ 2.0×ULN; serum heart rate≤ 2.0×ULN;
• LVEF determined by echocardiography≥ 50%;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Obtain informed consent signed by the patient or legal representative.

You may not qualify if:

• Acute promyelocytic leukemia, myeloid sarcoma, accelerated phase and blast of chronic myeloid leukemia;
• Patients with relapsed AML;
• Allergy to any drug involved in the program;
• Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
• Structural heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart disease, heart failure or myocardial infarction within 6 months prior to screening, resulting in clinical symptoms or abnormal cardiac function;
• Suffering from other malignant tumors at the same time; except for the following cases: ①Have received treatment for the purpose of cure, and have no known active malignance for ≥5 years before enrollment; ② Adequately treated non-melanoma skin cancer or malignant lentigo with no signs of disease (even if less than 3 years before randomization); ③ Adequately treated carcinoma in situ with no signs of disease (even if less than 3 years before randomization);
• AIDS patients, syphilis patients, active type Hepatitis B (HBV-DNA detectable) patients, and Hepatitis C patients;
• Any concurrent medical condition or disease (such as active systemic infection) that may interfere with study procedures or results, or which, in the judgment of the investigator, poses a risk to participation in this study；
• Inability to understand or comply with the research protocol;
• Received major surgery within 4 weeks before randomization;
• Participate in other clinical investigators at the same time one month before enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Affiliated Jiangning Hospital of Nanjing Medical University: collaborator
• Huai'an First People's Hospital: collaborator
• Yancheng First People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wenjie Liu, M.D

CONTACT

+8615895891160; dreaming88516@sina.com

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: February 27, 2022
• First Posted: March 3, 2022
• Study Start: March 1, 2021
• Primary Completion: June 28, 2023
• Study Completion: February 28, 2025
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)