A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

NCT06928376 | Active Not Recruiting Phase 2

• 1 other identifier: KY-2024-3-40-2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia; First Line Therapy

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission (CRc) Rate after 1 course of treatment

  a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)

  1 months after study treatment

Secondary Outcomes (9)

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

  1 months after the start of study treatment

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

  after 1 courses of chemotherapy (each course is 28 days)

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

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

• Event-free survival

  180 days after study treatment

• Overall Survival

  180 days after study treatment

Study Arms (2)

Venetoclax Combined With CACAG Regimen

EXPERIMENTAL

The CACAG+Venetoclax regimen has a total treatment period of 1 week, with a treatment cycle every 4 weeks, and a total of 1 course of treatment. Chidamide: 30 mg, twice a week, for a total of 2 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, continued until neutrophil recovery and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, when used in combination with azole drugs, the dosage is reduced to 100 mg/day.

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

Azacytidine (75 mg/m2/day, days 1 to 7). Cytarabine (75-100 mg/m2 bid, days 1 to 5). Aclacinomycin(20 mg/day, days 1,3,5). Chidamide (30 mg/day , days 1,4,8,11). Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). 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: Idarubicin (8-10 mg/m2) for 3 days . Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: Daunorubicin(60 mg/m2) for 3 days. 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:

• Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution

You may not qualify if:

• Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• First Affiliated Hospital of Harbin Medical University: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Chinese People's Liberation Army Air Force General Hospital: collaborator
• The General Hospital of Western Theater Command: collaborator
• 940 Hospital of the People's Liberation Army Joint Logistic Support Force: collaborator
• The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army: collaborator
• the First People's Hospital of Jining: 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 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: Director of the Department of Hematology

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: April 18, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: This study plans to share individual participant data (IPD) with qualified researchers after trial completion.
• Access Criteria: Data will be shared in a de-identified format to protect participant privacy. Researchers must submit a formal request outlining the purpose and analysis plan. Data use is restricted to research purposes only.

Locations

CN (1)