Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML

NCT05654194 | Unknown Phase 3

• 1 other identifier: SOOCHOW-HY-2022-11-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.

Conditions

Acute Myeloid Leukemia

Keywords

AML; Azacitidine; Venetoclax; ATRA

Outcome Measures

Primary Outcomes (1)

• Rate of the bone marrow complete response

  Rate of the bone marrow complete response after 1 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 1 cycle of inductive therapy

  after completion of one induction courses (1st Induction Course is 28 days) and before starting of the 2nd cycle

Secondary Outcomes (5)

• Rate of the bone marrow complete response after 2 cycle of inductive therapy

  after completion of two induction courses (1st Induction Course is 28 days) and before starting of the 1st Consolidation cycle

• Minimal Residual Disease (MRD) response

  after completion of two induction courses (one Course is 28 days) and before starting of the 1st Consolidation cycle

• Overall Survival (OS)

  2 years

• Event Free Survival（EFS）

  2 years

• Number of adverse events

  2 years

Study Arms (1)

AVA（Azacitidine Combined With Venetoclax and ATRA）group

EXPERIMENTAL

(1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28,every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month untill progression;

Drug: Azacitidine Combined With Venetoclax and ATRA group

Interventions

Azacitidine Combined With Venetoclax and ATRA group DRUG

AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28,every 28 days for up to 2 cycles as the inductive therapy.ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles for consolidate therapy.ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month for Maintenance therapy

Also known as: AVA group

AVA（Azacitidine Combined With Venetoclax and ATRA）group

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
• Age ≥ 18years.
• ECOG score: 0-3.
• White blood cell count ≤ 25\*10\^9/L
• Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
• AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
• Creatinine clearance ≥30ml/min

You may not qualify if:

• Pregnancy or lactation.
• Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
• Another malignant disease.
• Uncontrolled active infection.
• Left ventricular ejection fraction \< 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
• Active hepatitis B or hepatitis C infection.
• HIV infection.
• Other commodities that the investigators considered not suitable for the enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

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

Study Officials

• Yue Han, PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Han, PhD

CONTACT

8613901551669; hanyue@suda.edu.cn

Chengyuan Gu, MD

CONTACT

8618068016508; guchengyuan@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 16, 2022
• Study Start: October 31, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2025
• Last Updated: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)