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Monoclonal Antibodies
JNJ-67571244 for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
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 approximately 2.3 years
Awards & highlights
Study Summary
This study is evaluating whether a drug may help treat a type of leukemia.
Eligible Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2.3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2.3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
+1 moreSecondary outcome measures
Number of Participants with Depletion of CD33-Expressing Cells
Part 1 and 2: Concentration of Markers of T-Cell Activation
Part 1 and 2: Number of Participants with JNJ-67571244 Antibodies
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Participants in 2 expansion cohorts of acute myeloid leukemia (AML) or either high-risk myelodysplastic syndromes (MDS) or very high-risk MDS will receive JNJ-67571244 at the RP2D determined in Part 1.
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
Participants will receive JNJ-67571244. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-67571244
2019
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,240 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,837 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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