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Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
N/A
Waitlist Available
Led By Brittany Ragon, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Toxicity side effect
Secondary study objectives
Disease Response
Dose Modification
Dose modification due to nausea or diarrhea
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AML participants who are receiving or are planned to receive azacitidine plus venetoclaxExperimental Treatment1 Intervention
Buccal swabs for SNPs and pharmacogenomic analysis will be collected at baseline. 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.
Find a Location
Who is running the clinical trial?
Swim Across AmericaUNKNOWN
10 Previous Clinical Trials
353 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,285 Total Patients Enrolled
Atrium Health Levine Cancer InstituteOTHER
27 Previous Clinical Trials
3,743 Total Patients Enrolled
Brittany Ragon, MDPrincipal InvestigatorAtrium Health Wake Forest Baptist Comprehensive Cancer Center