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NCT02921061 · ClinicalTrials.gov registry record · Phase 1

Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS

A Phase 1 study of Refractory Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT02921061 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 28 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02921061, a Phase 1 study of Refractory Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial studies the side effects and best dose of decitabine when given together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed, has come back or has not responded to treatment. Drugs used in chemotherapy, such as decitabine, cladribine, cytarabine, and mitoxantrone hydrochloride 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. Decitabine, filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride may work better in treating patients with acute myeloid leukemia and myelodysplastic syndrome.

Interventions

  • DRUG Cladribine
  • DRUG Decitabine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Cytarabine
  • BIOLOGICAL Filgrastim

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2016-11-17
Est. Completion 2018-10-24
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT02921061

The ClinicalTrials.gov registry entry for NCT02921061 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cladribine is the first listed.

NCT02921061 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT02921061 about?

NCT02921061 is a clinical study titled "Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS". This phase I/II trial studies the side effects and best dose of decitabine when given together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed, has come back or has not respon...

What is the current status of trial NCT02921061?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2016-11-17. Estimated completion is 2018-10-24.

What conditions does trial NCT02921061 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia, Previously Treated Myelodysplastic Syndrome.

What interventions are being tested in trial NCT02921061?

The interventions under investigation include: Cladribine (DRUG), Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Filgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT02921061?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02921061 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.