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

NCT ID: NCT05659992

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-25
• Study Completion Date: 2024-08-14

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.

Detailed Description

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Conditions

Acute Myeloid Leukemia

Study Design

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

Study Groups

treatment group

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.

Group Type: EXPERIMENTAL

azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte

Intervention Type: 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)

Interventions

azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daihong Liu

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daihong Liu Liu, doctor

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40079007 (View on PubMed)

Other Identifiers

S2022-240

Identifier Type: -

Identifier Source: org_study_id