Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia

NCT06068621 | Completed Phase 2

• 1 other identifier: S2023-056-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; First Line Therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) after 1 course of treatment

  Defined as the percentage of participants achieving a best overall response of complete response (CR) or CR with incomplete blood count recovery (CRi).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.

  1 months after the start of study treatment

Secondary Outcomes (9)

• Complete Remission (CR) Rate after 1 course of treatment

  2 months after study treatment

• Complete Remission (CR) Rate after 2 courses of treatment

  after two courses of chemotherapy (each course is 28 days)

• Overall Response Rate (ORR) after 2 course of treatment

  after two courses of chemotherapy (each course is 28 days)

• Rate of Minimal Residual Disease (MRD)-Negative Response

  after two courses of chemotherapy (each course is 28 days)

• Event-free survival

  180 days after study treatment

Study Arms (2)

Venetoclax Combined With CACAG Regimen

EXPERIMENTAL

Venetoclax combined with CACAG regimen for newly diagnosed AML. Recipients were randomized and those entering the experimental group received azacytidine, cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg/m2/day from day 1 to day 7. Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5. Chidamide was used as 30 mg/day on days 1,4,8,11. Venetoclax was used as 400 mg/day from day 1 to day 14;Combined with posaconazole, reduced to 100 mg/day;Combined with voriconazole, reduced to 200 mg/day.Granulocyte colony-stimulating factor was used as 300 μg/day from day 0 until agranulocytosi recovery .

Drug: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

"3+7" Regimen

ACTIVE COMPARATOR

Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.

Drug: "3+7"

Interventions

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor DRUG

1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 bid, days 1 to 5). 3. Aclacinomycin(20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). 6. Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)

Also known as: CACAG+VEN

Venetoclax Combined With CACAG Regimen

"3+7" DRUG

IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days . 2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1. Daunorubicin(60 mg/m2) for 3 days. 2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.

Also known as: IA or DA

"3+7" Regimen

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are able to understand and willing to sign the informed consent form (ICF).
• All patients should aged 14 to75 years,no gender limitation.
• Patients who are newly diagnosed with AML(no M3).
• Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
• Renal function: creatinine ≤the upper limit of normal;
• Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
• The score of Eastern Cooperative Oncology Group (ECOG) is 0-2, and the predicted survival ≥ 4 months.
• Patients without severe allergic constitution.

You may not qualify if:

• Patients with allergy or contraindication to the study drug;
• Female patients who are pregnant or breast-feeding.
• Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
• Patients with mental illness or other states unable to comply with the protocol;
• Less than 6 weeks after surgical operation of important organs.
• Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\> 2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal;
• The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Sponsors & Collaborators

• 940 Hospital of the People's Liberation Army Joint Logistic Support Force: collaborator
• Chinese PLA General Hospital: lead
• The General Hospital of Western Theater Command: collaborator
• The General Hospital of Northern Theater Command: collaborator
• The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army: collaborator
• Air Force Military Medical University, China: collaborator
• Yantai Yuhuangding Hospital: collaborator
• People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center: collaborator
• First Hospital of China Medical University: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• Daihong Liu, doctor

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: March 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)