Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML

NCT ID: NCT05654194

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2025-03-31

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.

Detailed Description

This study include newly diagnosed AML patients who will accept the therapy with AZA combined with venetoclax and ATRA: (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 till progression;

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVA（Azacitidine Combined With Venetoclax and ATRA）group

(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;

Group Type: EXPERIMENTAL

Azacitidine Combined With Venetoclax and ATRA group

Intervention Type: 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

Interventions

Azacitidine Combined With Venetoclax and ATRA group

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

Intervention Type: DRUG

Other Intervention Names

AVA group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yue Han, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

the First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Han, PhD

Role: CONTACT

hanyue@suda.edu.cn

8613901551669

Chengyuan Gu, MD

Role: CONTACT

guchengyuan@suda.edu.cn

8618068016508

Facility Contacts

Chengyuan Gu, MD

Role: primary

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

SOOCHOW-HY-2022-11-2

Identifier Type: -

Identifier Source: org_study_id