Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML

NCT06536010

Acute Myeloid Leukemia

RECRUITING NA

Venetoclax and Azacitidine Combined With Homoharringtonine, Followed by Allo-HSCT for Intermediate and High-risk AML.

NCT06483906

Acute Myeloid Leukemia

RECRUITING PHASE2

CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

NCT06470841

Acute Myeloid Leukemia

NOT_YET_RECRUITING PHASE2

A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

NCT05662956

Acute Myeloid Leukemia

COMPLETED PHASE2

A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.

NCT05893472

Acute Myeloid Leukemia Venetoclax

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intermediate Risk Acute Myeloid Leukemia High Risk Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VA combined with HAAG

This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients.

Group Type EXPERIMENTAL

venetoclax, azacitidine and HAAG regimen

Intervention Type DRUG

Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

venetoclax, azacitidine and HAAG regimen

Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
2. Age 18-65.
3. ECOG score: 0-2.
4. No history of previous chemotherapy or target therapy.
5. Serum total bilirubin \<= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \<= 1.5 times ULN, aspartate aminotransferase (AST) \<=1.5 times ULN;
6. Creatinine clearance rate \>=30 mL/min;
7. Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
8. Capable to understand and willing to participate in this study, signed the informed consent form.

Exclusion Criteria

1. AML transformed with chronic myelogenous leukemia.
2. Acute promyelocytic leukemia (type M3).
3. Patients with a second malignancy requiring treatment.
4. Patients with uncontrolled active infection.
5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with hepatic and renal inadequacy: total serum bilirubin \>=2.0 mg/dl, AST \>=3 times ULN, serum creatinine clearance (Ccr) \<50 ml / min.
7. Patients with arterial oxygen saturation (SpO 2) was \<95%.
8. Patients with HIV infection.
9. Patients with active hepatitis B or hepatitis C infection.
10. Patients with other commodities that the investigators considered not suitable for the enrollment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No