Biopsy for Leukemia, Myelocytic, Acute

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Leukemia, Myelocytic, Acute+3 More
Biopsy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. Biopsy is being used to treat acute myelocytic leukemia and will not have a placebo group. This is not the first time Biopsy has been approved by the FDA, as it has been approved for a different condition in the past.

Eligible Conditions

  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Myelocytic, Acute

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Month 12
Overall treatment failure
Up to 2 years
Difference in treatment failure rates between the two arms
Up to 5 years
Duration of response
Overall survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Leukemia, Myelocytic, Acute

Trial Design

2 Treatment Groups

Arm B (azacitidine, venetoclax, enasidenib, ivosidenib)
1 of 2
Arm A (ivosidenib, enasidenib, azacitidine venetoclax)
1 of 2
Experimental Treatment

125 Total Participants · 2 Treatment Groups

Primary Treatment: Biopsy · No Placebo Group · Phase 2

Arm B (azacitidine, venetoclax, enasidenib, ivosidenib)Experimental Group · 5 Interventions: Ivosidenib, Azacitidine, Enasidenib, Biopsy, Venetoclax · Intervention Types: Drug, Drug, Drug, Procedure, Drug
Arm A (ivosidenib, enasidenib, azacitidine venetoclax)Experimental Group · 5 Interventions: Ivosidenib, Azacitidine, Enasidenib, Biopsy, Venetoclax · Intervention Types: Drug, Drug, Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1680
Enasidenib
2014
Completed Phase 2
~80
Biopsy
2014
Completed Phase 4
~1120
Venetoclax
2019
Completed Phase 3
~2040

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
0 TrialsResearching Leukemia, Myelocytic, Acute
210 CompletedClinical Trials

Who is running the clinical trial?

Alice MimsLead Sponsor
Alice S Mims, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a creatinine clearance of > 40 ml/min.
You have a performance status of 0-2.
Total bilirubin is less than 1.5 times the upper limit of normal.
You are of childbearing potential and willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 30 days following the last dose of either study drug.
You are of childbearing potential and willing to refrain from intercourse or use a protocol recommended method of contraception from the start of study treatment throughout the study treatment period and for 90 days following the last dose of either study drug.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.