BST-236 for Adult Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Virginia Cancer Center, Charlottesville, VA
Adult Acute Myeloid Leukemia
BST-236 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

An open label multi centre study to assess the safety and efficacy of BST-236 in combination with venetoclax in adult patients unfit for standard therapy with newly diagnosed Acute Myeloid Leukemia (AML) Part 1 of the study will define the maximal tolerate dose of the combination treatment, while part 2 will expend the chosen dose, to assesses efficacy and safety of this combination. All patients will receive 2 induction courses with both BST-236 and venetoclax, responding patients will then be followed with up to 3 maintenance courses with BST-236 alone. Patients will be followed for 1 year in the study and additional 1 year in post study follow-up

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Adult Acute Myeloid Leukemia

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to day 42

Up to day 42
Dose limiting toxicity and maximal tolerated dose for part 2
Day 42
In part 2

Trial Safety

Safety Progress

1 of 3

Other trials for Adult Acute Myeloid Leukemia

Trial Design

1 Treatment Group

Treatment
1 of 1
Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: BST-236 · No Placebo Group · Phase 1 & 2

TreatmentExperimental Group · 2 Interventions: venetoclax, BST-236 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venetoclax
2014
Completed Phase 3
~200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 42
Closest Location: University of Virginia Cancer Center · Charlottesville, VA
Photo of virginia 1Photo of virginia 2Photo of virginia 3
2011First Recorded Clinical Trial
2 TrialsResearching Adult Acute Myeloid Leukemia
103 CompletedClinical Trials

Who is running the clinical trial?

BioSight Ltd.Lead Sponsor
3 Previous Clinical Trials
125 Total Patients Enrolled
1 Trials studying Adult Acute Myeloid Leukemia
40 Patients Enrolled for Adult Acute Myeloid Leukemia

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a WBC count of <25,000/μL.
AST and/or aALT ≤2.5 times ULN.
You are 75 years of age or older.
Creatinine clearance ≥ 45 mL/min.
You have a score of 0 to 3 for patients <75 years of age.

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.