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Recruiting NCT06928376

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

Phase II Interventional Acute Myeloid Leukemia First Line Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor, "3+7".
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, First Line Therapy. Basic parameters: 14 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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).

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.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.

Interventions

  • Drug Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
    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)
  • Drug "3+7"
    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.

Primary outcome measures

  • Composite Complete Remission (CRc) Rate after 1 course of treatment [Time frame: 1 months after study treatment]
Secondary outcome measures (9)
  • Overall Response Rate (ORR) after 1 course of treatment [Time frame: 1 months after the start of study treatment]
  • Complete Remission (CR) Rate after 1 courses of treatment [Time frame: after 1 courses of chemotherapy (each course is 28 days)]
  • Rate of Minimal Residual Disease (MRD)-Negative Response [Time frame: after each courses of chemotherapy (each course is 28 days)]
  • Event-free survival [Time frame: 180 days after study treatment]
  • Overall Survival [Time frame: 180 days after study treatment]
  • Treatment-related adverse events [Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment]
  • Disease-free survival [Time frame: 180 days after study treatment]
  • Early death [Time frame: Within 30 days of the start of the first course of treatment]
  • 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)]

Eligibility criteria

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.)

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT06928376 · KY-2024-3-40-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗