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Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

NCT05342584 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-01-08

No results posted yet for this study

Summary

This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.

Conditions

Interventions

DRUG

Venetoclax Oral Tablet

Given PO

DRUG

Daunorubicin

Given IV

DRUG

Cytarabine

Given IV

Sponsors & Collaborators

Principal Investigators

  • Ioannis Mantzaris, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT05342584 on ClinicalTrials.gov