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A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia

NCT07754799 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-08-10

No results posted yet for this study

Summary

This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial.

A total of 320 patients will be enrolled in this study，and segregated into four groups with 80 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Daunorubicin

daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3,

DRUG

Cytarabine

Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7,

DRUG

Liposome Mitoxantrone

Liposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1,

DRUG

Venetoclax

Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po),

DRUG

Azacitidine

Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7,

DRUG

Venetoclax

Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts \>5%, then venetoclax 400 mg is continued on days 21-28.

DRUG

Daunorubicin

daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2,

DRUG

Cytarabine

Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5,

DRUG

Venetoclax

Venetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po),

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2029-09-30

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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 NCT07754799 on ClinicalTrials.gov