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NCT Number: NCT06928376

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

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).

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Key information

Conditions

Acute Myeloid Leukemia First Line Therapy Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.)

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Treatment and study plan

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)

Other names: CACAG+VEN

"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.

Other names: IA or DA

Primary outcomes

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

    Time frame: 1 months after study treatment

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

Secondary outcomes

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

    Time frame: 1 months after the start of study treatment

    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).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.

  2. Complete Remission (CR) Rate after 1 courses of treatment

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

    Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.

  3. Rate of Minimal Residual Disease (MRD)-Negative Response

    Time frame: after each courses of chemotherapy (each course is 28 days)

    Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry.

  4. Event-free survival

    Time frame: 180 days after study treatment

    Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.

  5. Overall Survival

    Time frame: 180 days after study treatment

    Defined as the time from joining the clinical study to death due to any cause.

  6. Treatment-related adverse events

    Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment

    Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.

  7. Disease-free survival

    Time frame: 180 days after study treatment

    Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.

  8. Early death

    Time frame: Within 30 days of the start of the first course of treatment

    Defined as death within 30 days of chemotherapy.

  9. Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment

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

    Disappearance of leukemia blasts in the bone marrow (<5% blasts) but without full recovery of blood counts (neutrophils <1.0 x 10⁹/L and/or platelets <100 x 10⁹/L).

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • 940 Hospital of the People's Liberation Army Joint Logistic Support Force
  • 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  • First Affiliated Hospital of Harbin Medical University
  • Jining First People's Hospital
  • The General Hospital of Western Theater Command
  • Yantai Yuhuangding Hospital

Registry information

Official study title

A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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