Study Summary
This trial is testing a new drug, pemigatinib, to see if it can help treat acute myeloid leukemia (AML). AML is a type of cancer that starts in the bone marrow (the soft tissue inside bones where blood cells are made). Pemigatinib works by inhibiting (blocking) a protein called FGFR (fibroblast growth factor receptor). This protein is involved in the growth of leukemia cells.
Eligible Conditions
- Acute Myeloid Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Date of first response (>= immune complete remission) till date of documented relapse assessed up to 2 years from last dose of study intervention
Day 1
Time-to-marrow recovery
Year 2
Relapse-free survival (RFS)
Year 2
Duration of remission (DOR)
Day 25
Rate of composite complete remission (cCR)
Year 2
Overall survival (OS)
Year 2
Event-free survival (EFS)
Day 42
Incidence of dose limiting toxicities (DLTs)
Day 90
Incidence of non-treatment related adverse events (AEs)
Incidence of treatment-emergent adverse events (TEAEs)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (cytarabine, daunorubicin, pemigatinib)
1 of 1
Experimental Treatment
32 Total Participants · 1 Treatment Group
Primary Treatment: Pemigatinib · No Placebo Group · Phase 1
Treatment (cytarabine, daunorubicin, pemigatinib)Experimental Group · 3 Interventions: Cytarabine, Pemigatinib, Daunorubicin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Pemigatinib
FDA approved
Daunorubicin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: date of first response (>= immune complete remission) till date of documented relapse assessed up to 2 years from last dose of study intervention
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
895 Previous Clinical Trials
6,831,273 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
315 Previous Clinical Trials
46,543 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
209 Previous Clinical Trials
2,089,538 Total Patients Enrolled
Elie Traer5.01 ReviewsPrincipal Investigator - OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a translocation t(6;9)(p23;q34.1).
You have a performance status of 0-2.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.
Patients must consent to a bone marrow aspirate/biopsy that will be collected prior to start of planned 7+3 induction therapy.
You have a translocation t(v;11q23.3); KMT2A rearranged.
The chromosomal abnormality t(9;22)(q34.1;q11.
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Conditions
Cancer Related
Treatments