Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML

NCT05513131 | Unknown Phase 2

• 1 other identifier: 2022-SR-376
• Study Type: interventional
• Target: 30
• 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 Azacitidine and Harringtonine) in patients with secondary AML This study involves the following: Venetoclax combined with Azacitidine and Harringtonine

Conditions

Secondary 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 Secondary Outcome Measures: Secondary Outcome Measures: 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 (1)

Venetoclax combined with Azacitidine and Harringtonine

EXPERIMENTAL

Venetoclax 100mg d1，200mg d2，400mg d3\~d14； Azacitidine 75mg/m2/d，d1\~d7； Homoharringtonine 2mg/d d1\~d7

Drug: Venetoclax；Azacitidine；Homoharringtonine

Interventions

Venetoclax；Azacitidine；Homoharringtonine DRUG

A cycle every 28 days Treatment with Venetoclax 100mg d1，200mg d2，400mg d3\~d14； Azacitidine 75mg/m2/d，d1\~d7 Homoharringtonine 2mg/d d1\~d7

Venetoclax combined with Azacitidine and Harringtonine

Eligibility Criteria

• Age: 18 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) newly diagnosed by bone marrow morphology and immunophenotyping (in line with the WHO 2016 diagnostic criteria), and meet any of the following conditions:
• Patients with treatment-related AML (tAML);
• AML patients with a previous history of MDS or CMML;
• AML patients with myelodysplasia-related cytogenetic abnormalities; 2) Age ≥ 18 years old, and age \< 80 years old; 3) Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 4) 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 myocardial enzyme \<2.0×ULN; 5) LVEF determined by echocardiography ≥50%; Obtain informed consent signed by the patient or legal representative.

You may not qualify if:

• \) AML with central nervous system (CNS) infiltration; 2) Acute promyelocytic leukemia confirmed by bone marrow morphology or immunophenotyping; 3) Have received Venetoclax treatment in the past; 4) Those who are known to be allergic to any drugs or other ingredients in the program; 5) Currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS; 6) Known human immunodeficiency virus (HIV) infection; 7) Known history of active hepatitis B or C (HBV, HCV) infection; 8) Pregnant women and women who are trying to conceive; 9) Suffering from severe and/or uncontrolled mental illness; 10) Any life-threatening disease, health condition, or organ system dysfunction that the investigator believes may compromise the safety of the subject, or create an undue risk to the research results; 11) 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

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Central Study Contacts

Huang Fei, MD

CONTACT

+8615950523133; 1533793080@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 24, 2022
• Study Start: September 30, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2025
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)