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Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML

NCT07172204 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-02-04

No results posted yet for this study

Summary

This phase II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.

Conditions

  • Intensive Chemotherapy Unfit
  • Newly Diagnosed Acute Myeloid Leukemia (AML)
  • Age ≥60

Interventions

DRUG

Alternately treated with VA/low CHA regimen

1. Induction Phase (4 alternating cycles): Participants will receive 4 cycles of alternating therapy: * VA Cycle: * Venetoclax 400 mg PO daily on Days 1-28 * Azacitidine 75 mg/m² SC daily on Days 1-7 * Low-dose CHA Cycle: * Cladribine 5 mg/m² IV daily on Days 1-3 * Homoharringtonine 1 mg/m² IV daily on Days 1-5 * Cytarabine 20 mg SC every 12 hours on Days 1-10 Alternating sequence: VA → CHA → VA → CHA → VA → CHA → VA → CHA 2. Maintenance Phase (24 months): Following induction, participants will receive: * Venetoclax 400 mg PO daily on Days 1-28 * Azacitidine 75 mg/m² SC daily on Days 1-7 Repeated every 28 days for 24 cycles. We aimed to compare this clinical intervention with standard VA which is: * Venetoclax 400 mg PO daily on Days 1-28 * Azacitidine 75 mg/m² SC daily on Days 1-7 Repeated every 28 days for at least 24 cycles.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jie Dr. Sun, M.D, Ph.D · Bone Marrow Transplantation Center of The First Affiliated Hospital, Zhejiang University School of Medicine

  • Shanshan Prof. Pei, Ph.D · Liangzhu Laboratory, Zhejiang University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2027-07-31
Completion
2029-07-31

Countries

  • China

Study Locations

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Entities

Companies

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 NCT07172204 on ClinicalTrials.gov