Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

NCT ID: NCT05807347

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-02-01

Brief Summary

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

Detailed Description

This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia(AML).

Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. Our preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for patients who were diagnosed with refreactory/relapse AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 42 patients will take part in this trial.

Conditions

Refractory/Relapse Acute Myeloid Leukemia

Study Design

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

Study Groups

VACAG（Venetoclax Combined with Azacitidine and CAG）regimen

Participants will receive induction as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

VA regimen Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7 Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7 Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC \>20×109/L

Interventions

Venetoclax

VA regimen Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7 Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7 Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC \>20×109/L

Intervention Type: DRUG

Other Intervention Names

Azacitidine; Cytarabine; Aclacinomycin; Granulocyte colony-stimulating factor

Eligibility Criteria

Inclusion Criteria

1. Patients ≥ 18 years old and ≤ 65 years old

2. Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification;

3. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;

4. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN

5. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN

6. Heart function: left ventricular ejection fraction ≧45%

7. Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Exclusion Criteria

1. Other diseases；

2. AML with central nervous system (CNS) infiltration；

3. Patients have received prior CAG or VA regimen before；

4. Patients with a life expectancy <3 months

5. Patients with uncontrolled active infection;

6. HIV infection;

7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. b) An active second cancer that requires treatment within 6 months of study entry

8. Female who are pregnant, breast feeding or childbearing potential.

9. Patients deemed unsuitable for enrollment by the investigator;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hematology department of the 920th hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lin Liu, Professor

Role: primary

Wangsanbin2022@126.com

0871-64774206

Other Identifiers

KM02

Identifier Type: -

Identifier Source: org_study_id