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NCT02728050 · ClinicalTrials.gov registry record · Phase 1
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT02728050: Completed Phase 1 study, sponsored by University of Washington.
NCT02728050 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02728050, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte colony-stimulating factor \[G-CSF\]), cladribine, cytarabine, and mitoxantrone, when given together with sorafenib and to see how well they work in treating patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome (likely to be more aggressive). Drugs used in chemotherapy, such as cladribine, cytarabine, and mitoxantrone 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. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and mitoxantrone together with sorafenib may kill more cancer cells.
Primary Outcome
MTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \>48 hours leading to \>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \<500/ µL or platelet count \<50,000/µL for \>
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Cladribine
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- BIOLOGICAL Filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2016-12-01 |
| Est. Completion | 2023-04-04 |
| Phase | Phase 1 |
What the finished NCT02728050 record still lists
NCT02728050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02728050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02728050 about?
NCT02728050 is a clinical study titled "Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte colony-stimulating factor \[G-CSF\]), cladribine, cytarabine, and mitoxantrone, when given together with sorafenib and to see how well they work in treating patients with newly-diagnosed acute myeloid leukemia or...
What is the current status of trial NCT02728050?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2016-12-01. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT02728050?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Cladribine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT02728050?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02728050's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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