CompletedPhase 2

Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia

United States36 participantsStarted 2018-11-28

Plain-language summary

This study aims to treat non-elderly adult patients, who were previously untreated for acute myeloid leukemia, using venetoclax and azacitidine.

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject must have confirmation of non-APL and AML by WHO criteria45
. Subject must have received no prior treatment for AML
. Age ≥18 years, ≤59 years
. Without clinical signs of active central nervous system disease
. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2
. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
. Subject must have adequate liver function as demonstrated by:
. Non-sterile male subjects must use contraceptive methods with partner(s) prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug.

Exclusion criteria

. Subject has received disease modifying treatment for myelodysplastic syndrome (MDS) or AML. ATRA given for clinical suspicion of APL will not be exclusionary and no washout will be required in this scenario.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response Rate, Measured by the European Leukemia Net Definition: (CRMRD-+CR+CRi+MLFS)

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Number of Participants That Achieved Minimal Residual Disease (MRD) Negative Responses

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Trial details

NCT IDNCT03573024

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-14

Results submitted2026-04-15

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject must have confirmation of non-APL and AML by WHO criteria45
. Subject must have received no prior treatment for AML
. Age ≥18 years, ≤59 years
. Without clinical signs of active central nervous system disease
. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2
. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
. Subject must have adequate liver function as demonstrated by:
. Non-sterile male subjects must use contraceptive methods with partner(s) prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug.

Exclusion criteria

. Subject has received disease modifying treatment for myelodysplastic syndrome (MDS) or AML. ATRA given for clinical suspicion of APL will not be exclusionary and no washout will be required in this scenario.

What they're measuring

Response Rate, Measured by the European Leukemia Net Definition: (CRMRD-+CR+CRi+MLFS)

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Number of Participants That Achieved Minimal Residual Disease (MRD) Negative Responses

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years