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Chemotherapy

BST-236 + Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by BioSight Ltd.
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 day 42
Awards & highlights

Study Summary

This trial will assess the safety and efficacy of BST-236 in combination with venetoclax for adult patients with newly diagnosed AML.

Who is the study for?
Adults diagnosed with Acute Myeloid Leukemia (AML) who are unfit for standard chemotherapy can join this trial. They must have a WBC count of <25,000/μL, creatinine clearance ≥45 mL/min, liver enzymes ≤2.5 times the upper limit of normal, and an ECOG performance status score that fits the age criteria. Pregnant women or those treated previously for MDS with certain drugs cannot participate.Check my eligibility
What is being tested?
The study is testing BST-236 combined with venetoclax to find out how safe and effective it is in treating AML patients who can't undergo standard therapy. The first part determines the highest dose patients can tolerate; the second part expands on this dose to further evaluate safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to drug infusion, organ inflammation due to immune response, fatigue from treatment burden, digestive issues like nausea or diarrhea, blood disorders such as low counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity and maximal tolerated dose for part 2
In part 2

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
BSR-236 + venetoclax
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venetoclax
2021
Completed Phase 2
~750
BST-236
2018
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

BioSight Ltd.Lead Sponsor
3 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

BST-236 (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05503355 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Treatment
Acute Myeloid Leukemia Clinical Trial 2023: BST-236 Highlights & Side Effects. Trial Name: NCT05503355 — Phase 1 & 2
BST-236 (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05503355 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this clinical trial?

"That is correct. The information available on clinicaltrials.gov verifies that this trial, which was first announced on 8/17/2022, is still recruiting patients. In total, they are looking for 80 individuals across 2 sites."

Answered by AI

Does this age group fall outside of the parameters for this clinical trial?

"According to the age requirements for participation that are listed in the inclusion criteria, the youngest somebody can be is 18 and the oldest they can be is 90."

Answered by AI

How can I get involved in this clinical trial?

"This trial is seeking 80 individuals who have recently been diagnosed with adult acute myeloid leukemia and are between 18-90 years old. The most notable requirements for candidates include: being adults ≥18 years of age, a diagnosis of AML that has not responded to prior treatment, an inability to receive standard induction chemotherapy, a white blood cell count of <25,000/μL, AST and/or aALT ≤2.5 X ULN), Total bilirubin ≤1.5 x ULN, 0 to 2 for patients ≥75 years of age, Women of reproductive potential must have a negative serum pregnancy test within"

Answered by AI

Are people still being accepted into this experiment?

"Yes, this is an ongoing clinical trial that is currently recruiting patients. According to the latest update on 8/17/2022, they are looking for 80 patients at 2 sites."

Answered by AI
~34 spots leftby Aug 2025