Health TrialsbyHealthPanel

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

ConditionLeukemia, Myeloid, Acute
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information.

Age ≥ 18 years of age at the time of consent

Confirmed diagnosis of AML

Planned initial treatment with azacitidine and venetoclax

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen samples

    Other intervention

    Buccal swabs and Blood samples will be collected throughout study.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: AML participants who are receiving or are planned to receive azacitidine plus venetoclax1 intervention

Trial outcomes

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)

Time frame
From initiation of venetoclax through 30 days after last dose

Secondary outcomes

1

Dose Modification

A binary variable indicating whether a participant experienced a dose modification, including delay or reduction

Time frame
Approximately 6 months or until last dose of Venetoclax, whichever came first
2

Disease Response

For participants diagnosed with AML, response will be defined as a binary variable indicating if they had a Complete Remission (CR), Complete Remission with partial hematologic recovery (CRh), Complete Remission with incomplete hematologic recovery (CRi), Morphologic Leukemia-free state (MLFS), or partial response (PR) to induction therapy using the European LeukemiaNet (ELN 2022) criteria. Otherwise they will be considered a non-responder

Time frame
Up to 3 years
3

Venetoclax levels

Will be defined as the maximum concentration of Venetoclax and is measured at 6 months if the participant is still receiving venetoclax

Time frame
Approx 6 months
4

Overall survival

Duration of time from date of enrollment to death. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive

Time frame
Approx 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator

Swim Across America

Collaborator

Source ClinicalTrials.gov
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