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Bexmarilimab + Standard Care for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Mika Kontro, MD, PhD
Research Sponsored by Faron Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CMML and MDS patient with response failure to HMA or therapy regimen including HMA.
Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months from study start
Awards & highlights
Study Summary
This trial will study the safety & efficacy of a drug, bexmarilimab, when combined with standard care for MDS, CMML or AML; Phase 1 to identify recommended dose, Phase 2 to assess preliminary efficacy.
Who is the study for?
Adults with certain blood cancers like MDS, CMML-2, or AML who have specific risk levels or treatment histories can join. They need good kidney and liver function and a low enough white blood cell count. People with acute promyelocytic leukemia, poor physical status, recent transplants, active autoimmune diseases (with some exceptions), current heavy immunosuppression use, or recent other cancer treatments cannot participate.Check my eligibility
What is being tested?
The trial is testing Bexmarilimab combined with standard treatments Azacitidine and Venetoclax in patients with specific types of blood cancers. It's in two phases: the first to find the safest dose level of Bexmarilimab and the second to see how well it works at that dose for these conditions.See study design
What are the potential side effects?
While not specified here, drugs like Bexmarilimab may cause immune-related effects since they target the body’s immune system. Standard care drugs can lead to side effects such as nausea, fatigue, bleeding problems and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CMML or MDS did not improve with HMA treatment.
Select...
I have AML and cannot undergo standard treatment, but can take azacitidine-venetoclax.
Select...
My AML has returned or didn't respond after 1 treatment, and I need azacitidine.
Select...
I have been diagnosed with CMML-2 and need azacitidine treatment.
Select...
My MDS is classified as intermediate, high, or very high risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months from study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months from study start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission with incomplete blood recovery (CRi) for r/r AML.
Complete response (CR) rate for MDS and CMML-2.
Therapeutic procedure
+3 moreSecondary outcome measures
Anti-bexmarilimab antibody positivity occurrence rate pre-dose and at defined timepoints during treatment.
Clinical efficacy measures based on overall survival analyses defined as the length measured from study start to death from any cause up to 2 years.
Clinical efficacy measures based on progression free survival analyses defined as the time from study start to the date of documented disease progression or death from any cause, whichever occurs first, up to 2 years.
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AMLExperimental Treatment3 Interventions
Standard of care venetoclax and/or azacitidine as per label plus bexmarilmab
Group II: Phase 1 - Newly diagnosed AML patients non-fit for induction therapyExperimental Treatment3 Interventions
Standard of care azacitidine and venetoclax as per label; bexmarilimab 4 dose levels Q1W followed by Q2W; 28-day cycle
Group III: Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AMLExperimental Treatment2 Interventions
Standard of care azacitidine as per label; bexmarilimab 4 dose levels at once every week (Q1W) followed by once every 2 weeks (Q2W); 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Faron Pharmaceuticals LtdLead Sponsor
8 Previous Clinical Trials
625 Total Patients Enrolled
Mika Kontro, MD, PhDPrincipal InvestigatorHelsinki University Central Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have APL or CMML with a high white blood cell count.My physical condition limits my daily activities, except if I have newly diagnosed AML and am under 75.My CMML or MDS did not improve with HMA treatment.I have a severe liver condition or chronic ulcers.My kidneys are working well.I have AML and cannot undergo standard treatment, but can take azacitidine-venetoclax.My white blood cell count is below the required level for my leukemia type.I had a transplant from another person less than 6 months ago.It's been less than 21 days since my last IV cancer treatment or less than 14 days since my last oral cancer medication.My AML has returned or didn't respond after 1 treatment, and I need azacitidine.My liver is working well.I need steroids or other drugs to suppress my immune system.I haven't had immunotherapy or experimental treatments in the last 28 days.I have been diagnosed with CMML-2 and need azacitidine treatment.I have an autoimmune disorder, but it's not diabetes type I, celiac, controlled hypothyroidism, vitiligo, psoriasis, or alopecia.I am 18 years or older.My MDS is classified as intermediate, high, or very high risk.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AML
- Group 2: Phase 1 - Newly diagnosed AML patients non-fit for induction therapy
- Group 3: Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AML
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.
Are there any vacant slots available for participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this study is still actively seeking participants since its inaugural posting on June 2nd 2022 and final update on June 22nd 2023. 181 patients need to be recruited from 6 different medical centres."
Answered by AI
How many total participants have enrolled in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this experiment, which was instituted on June 2nd 2022, is currently recruiting patients. 181 participants must be sought from 6 different medical hubs."
Answered by AI
How geographically dispersed is this experimental protocol?
"As of now, the medical trial is recruiting individuals from 6 locales. These include Houston, Tampere and Helsinki with other sites available for selection. To reduce travelling costs associated with enrollment, it would be wise to select the nearest trial site location."
Answered by AI
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