Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT02521493 · View on ClinicalTrials.gov ↗

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

318 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02521493

The ClinicalTrials.gov registry entry for NCT02521493 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02521493 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02521493?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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