Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

NCT05659992 | Completed Phase 2

• 1 other identifier: S2022-240
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia

Keywords

Venetoclax; CACAG; AML

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).

  1 month after study treatment

Secondary Outcomes (7)

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

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

• Progression Free Survival (PFS)

  180 days after study treatment

• Overall Survival (OS)

  180 days after study treatment

• Rate of Participants With Adverse Events

  Through 28 days post last study medication administration

• Partial Remission (PR) Rate:

  1 month after study treatment

Study Arms (1)

treatment group

EXPERIMENTAL

Experimental: Venetoclax combined CACAG regimen for newly diagnosed AML. All recipients in this arm received azacytidine, cytarabine.aclamycin, chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5. Aclamycin was uesd as 10 mg/m2/day on day1,3,5). Chidamide was uesd as 30 mg/day twice per week for 2 weeks. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery.

Drug: azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte

Interventions

azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte DRUG

1. azacytidine (75 mg/m2/day, days 1 to 7). 2. cytarabine (75 mg/m2 bid, days 1 to 5). 3. aclamycin (10 mg/m2/day, day1,3,5). 4. Chidamide (30 mg/day , days 0,3). 5. venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ). 6. granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)

treatment group

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.
• 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 0-3,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 active infection
• 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

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Liu Q, Yang J, Lv L, Zhang X, Li M, Xu L, Huang S, Jing Y, Dou L. Phase 2 study of chidamide in combination with CAG and venetoclax-azacitidine in older patients with newly diagnosed acute myeloid leukemia. Front Immunol. 2025 Feb 26;16:1525110. doi: 10.3389/fimmu.2025.1525110. eCollection 2025.

  PMID: 40079007 DERIVED

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 Liu, doctor

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: December 25, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2024
• Last Updated: November 8, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)