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NCT04659616 · ClinicalTrials.gov registry record · Phase 1
Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia, sponsored by OHSU Knight Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT04659616: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by OHSU Knight Cancer Institute.
NCT04659616 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by OHSU Knight Cancer Institute. The registered enrollment target is 32 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04659616, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by OHSU Knight Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial identifies the best dose and clinical benefit of giving pemigatinib following standard induction chemotherapy in patients with newly diagnosed acute myeloid leukemia. Pemigatinib selectively inhibits FGFR (fibroblast growth factor receptor) activity, a receptor that may contribute to the growth of leukemia cells. The genetic changes responsible for activating the growth of leukemia cells can be unique to each patient and can change during the course of the disease. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Primary Outcome
Will be summarized using the proportion and exact binomial confidence interval. DLTs will be summarized at each dose level by severity and major organ site according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Bone Marrow Aspirate
- DRUG Cytarabine
- DRUG Daunorubicin
Study Locations (2)
Oregon
- OHSU Knight Cancer Institute - Portland
Texas
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT04659616 shows while recruiting
NCT04659616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04659616 reports a single indexed study location in Oregon, Texas.
Frequently Asked Questions
What is clinical trial NCT04659616 about?
NCT04659616 is a clinical study titled "Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia". This phase I trial identifies the best dose and clinical benefit of giving pemigatinib following standard induction chemotherapy in patients with newly diagnosed acute myeloid leukemia. Pemigatinib selectively inhibits FGFR (fibroblast growth factor receptor) activity, a receptor that may contribute...
What is the current status of trial NCT04659616?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2021-01-14. Estimated completion is 2026-12-31.
What conditions does trial NCT04659616 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04659616?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Bone Marrow Aspirate (PROCEDURE), Cytarabine (DRUG), Daunorubicin (DRUG).
Who is sponsoring clinical trial NCT04659616?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04659616 being conducted?
This trial has 2 study locations across Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04659616's enrollment target sits among peer trials
32 199th of 306 higher than 105 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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