NCT06810791

Brief Summary

The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
876

participants targeted

Target at P75+ for phase_3

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

January 16, 2025

Last Update Submit

February 4, 2025

Conditions

Newly Diagnosed Acute Myeloid Leukemia With High Risk

Keywords

HVA regimenIntensive chenmotherapyFitrandomized controlled trialPhase 3VEN combined with AZAUnfitNewly diagnosedHigh riskAcute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • Composite complete remission (CRc)

    CRc includes complete remission (CR) and complete remission accompanied with with incomplete count recovery (CRi).

    At the end of cycle 2 (each cycle is 28 days).

Secondary Outcomes (7)

  • Complete remission (CR)

    At the end of cycle 2 (each cycle is 28 days).

  • Overall response rate (ORR)

    At the end of cycle 2 (each cycle is 28 days).

  • DOR

    1 year

  • Rate of Measurable residual disease (MRD) negative

    At the end of cycle 2 (each cycle is 28 days).

  • Overall survival (OS)

    1 year

  • +2 more secondary outcomes

Study Arms (4)

IC regiment for Fit-AML

ACTIVE COMPARATOR
Drug: Standard Chemotherapy

HVA regiment for Fit-AML

EXPERIMENTAL
Drug: HVA

VA regiment for unfit-AML

ACTIVE COMPARATOR
Drug: VA

HVA regiment for unfit-AML

EXPERIMENTAL
Drug: HVA

Interventions

HVADRUG

Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.

HVA regiment for Fit-AMLHVA regiment for unfit-AML
VADRUG

VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.

VA regiment for unfit-AML
Standard ChemotherapyDRUG

Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.

IC regiment for Fit-AML

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • According to the world health organization (WHO) classification of newly diagnosed with AML patients;
  • Age ≥18 years old;
  • High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy.
  • Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine \< 1.0g/d) after the diagnosis of AML;
  • Expected survival ≥12 weeks;
  • The eastern tumor cooperation group (ECOG) score 3 points or less;
  • Kidney function: creatinine clearance acuity 30 ml/min;
  • Liver function: ALT \< 5 times normal value, bilirubin \< 3 times normal value;
  • Sign the informed consent form and understand and abide by the plan calls for process.

You may not qualify if:

  • Acute promyelocytic leukemia;
  • With central nervous system leukemia (CNSL) ;
  • The cardiac function \> level 2;
  • The AIDS virus (HIV) infection;
  • Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor;
  • Can't take oral treatment or having a gastrointestinal disease impact ing the absorption;
  • Being allergy to the experimental drugs;
  • Pregnant and lactating women;
  • Patients who could not understand or adhere to the study protocol;
  • Patients deemed by the investigator to be ineligible for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Guopan Yu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guopan Yu

CONTACT

+8615876559968yugpp@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with newly diagnosed AML with high risk will be divided into two cohorts, including patients being eligible for intensive chemotherapy and those with unfit status according to Ferrara 2013 criteria. In the fit cohort, patients will be randomized into accepting HVA versus IA/DA for induction with a ratio of 1:1. In the unfit cohort, patients will be randomized into accepting HVA versus VA for induction with a ratio of 1:1.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2025

First Posted

February 6, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)