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NCT02521493 · ClinicalTrials.gov registry record · Phase 3

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

A Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Children's Oncology Group.

Active
Registry status
Phase 3
Development phase
280
Enrollment target
20
Study locations

NCT02521493 is a Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 280 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (143% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT02521493, a Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Children's Oncology Group.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
280 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Interventions

  • DRUG Etoposide
  • DRUG Cytarabine
  • DRUG Asparaginase Erwinia chrysanthemi
  • DRUG Daunorubicin Hydrochloride
  • DRUG Asparaginase

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center - Downey
  • Loma Linda University Medical Center - Loma Linda
  • Miller Children's and Women's Hospital Long Beach - Long Beach
  • Children's Hospital Los Angeles - Los Angeles
  • Cedars Sinai Medical Center - Los Angeles
  • Valley Children's Hospital - Madera
  • UCSF Benioff Children's Hospital Oakland - Oakland
  • Kaiser Permanente-Oakland - Oakland
  • Children's Hospital of Orange County - Orange
  • Lucile Packard Children's Hospital Stanford University - Palo Alto
  • Sutter Medical Center Sacramento - Sacramento
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • Rady Children's Hospital - San Diego - San Diego
  • Naval Medical Center -San Diego - San Diego
  • UCSF Medical Center-Mission Bay - San Francisco

Arizona

  • Banner Children's at Desert - Mesa
  • Phoenix Childrens Hospital - Phoenix

Alabama

  • Children's Hospital of Alabama - Birmingham

Alaska

  • Providence Alaska Medical Center - Anchorage

Arkansas

  • Arkansas Children's Hospital - Little Rock

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2015-12-23
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT02521493

The ClinicalTrials.gov registry entry for NCT02521493 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (143% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

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

NCT02521493 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT02521493 about?

NCT02521493 is a clinical study titled "Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome". This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stoppi...

What is the current status of trial NCT02521493?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2015-12-23. Estimated completion is 2026-06-30.

What conditions does trial NCT02521493 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Down Syndrome, Myeloproliferative Neoplasm, Myeloid Leukemia Associated With Down Syndrome.

What interventions are being tested in trial NCT02521493?

The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Asparaginase Erwinia chrysanthemi (DRUG), Daunorubicin Hydrochloride (DRUG), Asparaginase (DRUG).

Who is sponsoring clinical trial NCT02521493?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02521493 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. 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.