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Anti-tumor antibiotic
BST-236 for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Research Sponsored by BioSight Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 times the upper limits of normal (ULN), unless attributed to leukemia (in AML patients)
Adult ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to be assessed 5 months after the last patient was enrolled to the study
Awards & highlights
Study Summary
This trial is testing a new cancer drug for patients with AML or MDS who have failed other treatments. Up to 40 patients will be enrolled, and they will be treated with 1-2 induction courses and 2-4 maintenance courses of the drug. All patients will be followed for 1 year in the study and additional 1 year post study follow-up.
Who is the study for?
This trial is for adults over 18 with relapsed/refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS), who can't have intensive chemotherapy and haven't responded to first-line therapies like azacitidine. They should be able to follow the study schedule, use effective birth control, and not be eligible for a bone marrow transplant at enrollment.Check my eligibility
What is being tested?
The trial tests BST-236 as a single agent in patients unfit for standard therapy. It aims to assess safety and efficacy in those who didn’t respond or relapsed after initial treatment. Participants will receive induction and maintenance courses of BST-236, followed by one year of study observation plus an additional year post-study.See study design
What are the potential side effects?
While specific side effects of BST-236 are not listed here, similar drugs often cause symptoms like nausea, fatigue, increased risk of infection due to low blood cell counts, bleeding complications from low platelets, and potential liver function abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within normal limits or slightly elevated due to my leukemia.
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I am 18 years old or older.
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My MDS did not improve after 4+ cycles of specific treatments in the last year.
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I can walk and take care of myself, but I cannot do any physical work.
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I have been diagnosed with AML with at least 20% blasts in my blood or bone marrow.
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My AML has returned after initial treatment success with specific drugs.
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My MDS worsened despite treatment with azacitidine or decitabine.
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My heart condition is stable and managed with medication.
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My kidney function, measured by creatinine clearance, is adequate.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with MDS and my risk score is 4.5 or higher.
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My AML worsened despite treatments like azacitidine or venetoclax.
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My AML didn't respond to specific treatments I received in the last year.
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I am over 18 and have a heart condition with an LVEF of 50% or less.
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My MDS has returned after treatment with azacitidine or decitabine.
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I cannot undergo intensive chemotherapy.
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I am 75 years old or older.
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I cannot have a bone marrow transplant from a donor at this time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to be assessed 5 months after the last patient was enrolled to the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be assessed 5 months after the last patient was enrolled to the study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CR rate
Overall response rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: BST-236Experimental Treatment1 Intervention
BST-236 Intravenous, 4.5 g/m^2/d or 2.3 g/m^2/d, for 6 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BST-236
2018
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
BioSight Ltd.Lead Sponsor
3 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with acute promyelocytic leukemia.My liver enzymes are within normal limits or slightly elevated due to my leukemia.I am allergic to drugs similar to BST-236 or cytarabine.I am 18 years old or older.I have been treated for AML or MDS, but not with HMA, LDAC, or their combinations with venetoclax.My MDS did not improve after 4+ cycles of specific treatments in the last year.I have a type of blood cancer such as CMML, atypical CML, JMML, or an unclassifiable MDS/MPN.My condition evolved from a previous blood disorder to MDS or AML.I can walk and take care of myself, but I cannot do any physical work.I have been diagnosed with AML with at least 20% blasts in my blood or bone marrow.I have been treated with high-dose cytarabine before.You have any medical or surgical condition, abnormal lab results, or mental health condition that could make it unsafe for you to participate in the study, as determined by the doctor in charge.My MDS worsened despite treatment with azacitidine or decitabine.My heart condition is stable and managed with medication.My kidney function, measured by creatinine clearance, is adequate.My AML has returned after initial treatment success with specific drugs.I can take care of myself but might not be able to do heavy physical work.My white blood cell count is high, but I can use treatments to lower it if needed.I have not taken HMA, LDAC, or venetoclax in the last 14 days.I have been diagnosed with MDS and my risk score is 4.5 or higher.I do not have an ongoing serious infection that isn't getting better with treatment.My AML worsened despite treatments like azacitidine or venetoclax.I agree to avoid unprotected sex and not donate sperm for 3 months after the last dose.I haven't had surgery (except for minor procedures) in the last 14 days.My AML didn't respond to specific treatments I received in the last year.I am over 18 and have a heart condition with an LVEF of 50% or less.My MDS has returned after treatment with azacitidine or decitabine.I am using two effective birth control methods as required.I was diagnosed with cancer, other than AML, in the last year, and it wasn't just skin cancer or a local cancer that was fully treated.My life expectancy is more than 3 months, not considering my AML/MDS condition.I cannot undergo intensive chemotherapy.I have had a stem cell or organ transplant in the past.I am 75 years old or older.I cannot have a bone marrow transplant from a donor at this time.
Research Study Groups:
This trial has the following groups:- Group 1: BST-236
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many centers are actively managing this clinical trial?
"Currently, 4 medical centres are running this trial. They can be found in Houston, Shreveport and Seattle with other sites situated nearby. It is encouraged that potential patients select the closest centre to them so as to reduce travel costs associated with participating."
Answered by AI
What is the scope of this research in terms of participant numbers?
"Affirmative, the information found on clinicaltrials.gov implies that this trial is currently recruiting individuals for participation. This medical study was first posted November 14th 2021 and has most recently been updated July 19th 2022. The recruitment goals are to bring in 40 participants from 4 distinct sites."
Answered by AI
Is participation in this research endeavor still an option?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, first posted on November 14th 2021, is actively looking for enrollees. 40 volunteers are needed to be recruited from 4 different medical centres."
Answered by AI
What kind of deleterious effects could arise from using BST-236?
"The safety rating of BST-236 is 2, as there are records indicating its general safety but no scientific evidence supporting efficacy."
Answered by AI
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