Demethylation Agent
Biopsy for Acute Myeloid Leukemia
Ohio State University Comprehensive Cancer Center, Columbus, OH
Biopsy +4 morePhase 2RecruitingLed by Alice S Mims, MDResearch Sponsored by Alice MimsEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 5 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is comparing two different ways of treating older patients with a specific type of leukemia. The first treatment method uses a drug to target IDH1 or IDH2 mutations, followed by a combination of azacitidine and venetoclax. The second treatment method uses azacitidine and venetoclax first, followed by the IDH1 or IDH2 inhibitor. Researchers will compare how well each treatment method works and what side effects occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall treatment failure
Secondary outcome measures
Difference in treatment failure rates between the two arms
Duration of response
Overall survival (OS)
Side effects data
From 2015 Phase 2 trial • 59 Patients • NCT021502135%
Renal Cyst
5%
Adrenal Adenoma
2%
Angiomyolipoma
2%
Ovarian cyst
100%
80%
60%
40%
20%
0%
Study treatment Arm
BGG492
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (Ven+aza followed by IDHi+aza)Experimental Treatment5 Interventions
For both IDH1 and IDH2 mutated AML patient randomized to first-line therapy with Ven+aza, patients will receive venetoclax dosing with the ramp-up and dosing per the FDA-label (based off of concurrent drug interactions). Azacitidine will be given intravenously at 75mg/m2 daily on days 1-7 of each 28-day cycle. Subsequent cycles may be adjusted in timing and dosing based off the FDA-label for the combination therapy based off cytopenias or other toxicities.
Group II: Arm A (IDHi+Aza followed by Ven+aza)Experimental Treatment5 Interventions
For IDH1 mutated AML patients randomized to first-line therapy with IDHi+aza, patients will receive Ivosidenib 500mg po orally daily on Days 1-28 of each 28 day cycle. For IDH2 mutated AML patients randomized to first-line therapy with IDHi+aza, patients will receive Enasidenib 100mg po orally daily on Days 1-28 of each 28 day cycle. Azacitidine will be given to both groups intravenously at 75mg/m2 daily on days 1-7 of each 28 day cycle. Subsequent cycles may be adjusted in timing and dosing based off the FDA-label for the combination therapy based off cytopenias or other toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2170
Azacitidine
2012
Completed Phase 3
~1310
Biopsy
2014
Completed Phase 4
~1120
Enasidenib
2020
Completed Phase 2
~120
Find a site
Who is running the clinical trial?
Alice MimsLead Sponsor
1 Previous Clinical Trials
23 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,412 Previous Clinical Trials
41,238,941 Total Patients Enrolled
Alice S Mims, MDPrincipal Investigator
Ohio State University Comprehensive Cancer CenterMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Biopsy received the green light from the FDA?
"While there is evidence of Biopsy's safety, efficacy data has yet to be collected. This leads our team at Power to give the medication a score of 2 on a scale from 1-3."
Answered by AI
Is this clinical investigation still welcoming participants?
"According to clinicaltrials.gov, this medical study has concluded its recruitment process as of June 30th 2022. Initial posting was on August 1st 2022. However, there are currently 1534 other trials actively seeking participants at the moment."
Answered by AI