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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: Active Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Children's Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Kaplan-Meier method will be used to estimate 2-year EFS separately for standard risk and high risk patients. EFS is defined as the time from the end of Induction I to failure to achieve remission at the end of Induction II, relapse, occurrence of a second malignancy, or death.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT02521493 still lists
NCT02521493 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (143% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT02521493's enrollment target sits among peer trials
280 30th of 306 higher than 277 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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