NCT06580106

Brief Summary

The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
45mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Apr 2025Jan 2030

First Submitted

Initial submission to the registry

August 14, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

April 9, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

August 14, 2024

Last Update Submit

January 30, 2026

Conditions

Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (1)

  • Toxicity side effect

    Defined as a binary variable indicating whether a participant experienced a Grade 3 or higher of specific side effects (including infections, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, diarrhea)

    From initiation of venetoclax through 30 days after last dose

Secondary Outcomes (6)

  • Dose Modification

    Approximately 6 months or until last dose of Venetoclax, whichever came first

  • Disease Response

    Up to 3 years

  • Venetoclax levels

    Approx 6 months

  • Overall survival

    Approx 3 years

  • Dose modification due to nausea or diarrhea

    Approximately 6 months or until last dose of Venetoclax, whichever came first

  • +1 more secondary outcomes

Study Arms (1)

AML participants who are receiving or are planned to receive azacitidine plus venetoclax

Buccal swabs for SNPs and pharmacogenomic analysis can occur at any point before or after starting treatment during the study period. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. CYP3A activity will also be evaluated. Demographic and cancer related history will be acquired for each participant. During study participation, cancer treatment details including administration, dose modifications, delays, and reductions, including specific grade 3 toxicities, stem cell transplant status, symptom burden, disease response, and survival will be collected. Participants will be taken off study after three years.

Other: Biospecimen samples

Interventions

Biospecimen samplesOTHER

Buccal swabs and Blood samples will be collected throughout study.

AML participants who are receiving or are planned to receive azacitidine plus venetoclax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with AML who are receiving or are planned to receive azacitidine plus venetoclax will be identified in clinic and presented informed consent for this study.

You may qualify if:

  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age ≥ 18 years of age at the time of enrollment
  • Confirmed diagnosis of AML
  • Planned initial treatment with azacitidine and venetoclax
  • Ability to read and understand the English and/or Spanish language
  • As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Brittany Ragon, MD

    Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Schepel

CONTACT

(980) 292-0817courtney.schepel@advocatehealth.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 30, 2024

Study Start

April 9, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2030

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)