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A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia

NCT07743112 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-08-03

No results posted yet for this study

Summary

This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.

Conditions

Interventions

DRUG

MAX-40279

Dose escalation：MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.

DRUG

Azacitidine

Given by IV, 75 mg/m2

DRUG

Venetoclax

100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.

Sponsors & Collaborators

  • Maxinovel Pty., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianxiang Wang, MD · Institute of Institute of Hematology & Blood Diseases Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2027-09-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743112 on ClinicalTrials.gov