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Monoclonal Antibodies
Cohort 0-b for Acute Myeloid Leukemia (VOYAGE Trial)
Phase 1 & 2
Waitlist Available
Led By John DiPersio, MD, PhD
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acceptable laboratory parameters and adequate organ reserve
Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, up to 3 years.
Awards & highlights
VOYAGE Trial Summary
This trial is testing a new cancer drug, flotetuzumab, to see if it is effective and safe for people with a certain type of leukemia. The study is divided into three parts. The first part is to test different doses of the drug to see what is safe. The second part is to see if the drug has any anti-cancer activity. The last part is to see how long the drug works.
VOYAGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVOYAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study, up to 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy Based on CR or CRh Rate
Secondary outcome measures
CR Rate
CRh Rate
Duration of Hospitalization for Patients in the Expansion Cohort
+19 moreVOYAGE Trial Design
13Treatment groups
Experimental Treatment
Group I: MTD expansion with RuxolitinibExperimental Treatment2 Interventions
Group II: MTD ExpansionExperimental Treatment1 Intervention
Group III: Cohort 8Experimental Treatment1 Intervention
Group IV: Cohort 7Experimental Treatment1 Intervention
Group V: Cohort 6Experimental Treatment1 Intervention
Group VI: Cohort 3Experimental Treatment1 Intervention
Group VII: Cohort 2aExperimental Treatment1 Intervention
Group VIII: Cohort 2Experimental Treatment1 Intervention
Group IX: Cohort 1Experimental Treatment1 Intervention
Group X: Cohort 0-dExperimental Treatment1 Intervention
Group XI: Cohort 0-cExperimental Treatment1 Intervention
Group XII: Cohort 0-bExperimental Treatment1 Intervention
Group XIII: Cohort 0-aExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
MacroGenicsLead Sponsor
48 Previous Clinical Trials
4,850 Total Patients Enrolled
John DiPersio, MD, PhDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
47 Total Patients Enrolled
Stephen L. Eck, MD, PhDStudy DirectorMacroGenics
1 Previous Clinical Trials
82 Total Patients Enrolled
Frequently Asked Questions
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