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

NCT06394011 | Recruiting Phase 2 DMC

• 1 other identifier: VA+HAAG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intermediate Risk Acute Myeloid Leukemia; High Risk Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Composite complete response rate (CRc; CR+CRi)

  CRc includes complete response CR and CRi; CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia.

  Day 28-35 of induction course

Secondary Outcomes (4)

• Partial remission (PR)

  Day 28-35 of induction course

• Number of adverse events

  2 years

• Relapse-free survival (RFS)

  3 years

• Overall survival (OS)

  3 years

Study Arms (1)

VA combined with HAAG

EXPERIMENTAL

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

Drug: venetoclax, azacitidine and HAAG regimen

Interventions

venetoclax, azacitidine and HAAG regimen 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;

VA combined with HAAG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
• Age 18-65.
• ECOG score: 0-2.
• No history of previous chemotherapy or target therapy.
• 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;
• Creatinine clearance rate \>=30 mL/min;
• Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
• Capable to understand and willing to participate in this study, signed the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

venetoclax; Azacitidine

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Xiaowen Tang, Ph.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Xiaowen Tang, Ph.D

CONTACT

(0086)51267780086; xwtang1020@163.com

Depei Wu, Ph.D

CONTACT

(0086)51267780086; drwudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-01

Locations

CN (1)