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Vibecotamab for Acute Myeloid Leukemia
Study Summary
This trial will test a new cancer drug, vibecotamab, to see if it is safe and effective in patients with leukemia or myelodysplastic syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My AML shows signs of returning or not going away, with a specific test result.My MDS blasts are at least 20% positive for CD123.I can walk and care for myself but cannot do any physical work.My partner and I agree to use effective birth control and I won't donate sperm while on vibecotamab and for 4 weeks after.I haven't taken any cancer medication in the last 7 days or 5 half-lives.I am expected to undergo a stem cell transplant within the next 30 days.I do not have severe liver, kidney, heart problems, or uncontrolled infections.My leukemia cells show at least 20% CD123 expression.I have previously been treated with vibecotamab or anti-CD123 therapy.I have HIV with a detectable viral load.I am 18 years old or older.My AML is in remission after intensive chemotherapy.I will use effective birth control during and for 4 weeks after my last dose of vibecotamab.My MDS is high risk and didn't improve after 4+ cycles of specific treatments.
- Group 1: AML MRD cohort only
- Group 2: MDS post-HMA failure cohort only
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has Vibecotamab obtained regulatory clearance from the Food and Drug Administration?
"Vibecotamab's safety is rated a 2 because there exist pre-clinical data supporting its security, yet no evidence to suggest that it works in this capacity."
Are there any vacancies left in this healthcare experiment?
"As indicated by clinicaltrials.gov, this medical trial is actively enrolling participants. The listing was first published on May 6th 2022 and edited as recently as September 29th of the same year."
What is the upper limit of patients enrolled in this medical experiment?
"Affirmative. According to the clinicaltrials.gov platform, this study has been opened for recruitment since May 6th 2022 and recently updated on September 29th of the same year. 40 participants are needed from a single medical centre."
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