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Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

NCT04801797 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-05-12

No results posted yet for this study

Summary

This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia.

This study involves the following:

* Venetoclax and azacitidine (investigational combination)
* Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)

Conditions

Interventions

DRUG

Cytarabine

Intravenous infusion

DRUG

Idarubicin

Intravenous infusion

DRUG

Daunorubicin

Intravenous infusion

DRUG

Liposomal daunorubicin and cytarabine

Intravenous infusion

DRUG

Venetoclax

Orally by mouth

DRUG

Azacitidine

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Amir T Fathi, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2027-01-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04801797 on ClinicalTrials.gov