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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. MTD is defined as the highest dose studied in which the incidence of DLT is \< 33%. Each participant was monitored for DLTs in the first 20 days of treatment. DLTs monitored included 1. any grade 3 non-hematologic toxicity lasting more than 48 hours that resulted in more than a 7 day delay of the subsequent treatment cycle (except for febrile neutropenia or infection) 2. any grade 4 or g

Conditions Studied

Refractory Acute Myeloid Leukemia Mixed Phenotype Acute Leukemia Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia Previously Treated Myelodysplastic Syndrome Recurrent High Risk Myelodysplastic Syndrome Refractory High Risk 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
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT02921061 record still lists

NCT02921061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02921061's enrollment target sits among peer trials

28 39th of 63 higher than 24 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02921061, the US trial registry maintained by the National Library of Medicine. NCT02921061 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.