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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 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 84 participants.

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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.

Interventions

  • OTHER Quality-of-Life Assessment
  • DRUG Cladribine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Cytarabine
  • BIOLOGICAL Filgrastim

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2016-12-01
Est. Completion 2023-04-04
Phase Phase 1

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT02728050

The ClinicalTrials.gov registry entry for NCT02728050 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT02728050 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.