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NCT03263936 · ClinicalTrials.gov registry record · Phase 1
Epigenetic Reprogramming in Relapse/Refractory AML
A Phase 1 study of Acute Myelogenous Leukemia, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT03263936: Completed Phase 1 study of Acute Myelogenous Leukemia, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT03263936 is a Phase 1 study of Acute Myelogenous Leukemia that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 37 participants, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263936, a Phase 1 study of Acute Myelogenous Leukemia, has completed, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).
Primary Outcome
The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Decitabine
- DRUG Cytarabine
- DRUG Vorinostat
- DRUG Filgrastim (G-CSF)
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital Orange County - Orange
- UCSF School of Medicine - San Francisco
Maryland
- Johns Hopkins University - Baltimore
- Sidney Kimmel Cancer Center at Johns Hopkins - Baltimore
- National Cancer Institute, Pediatric Oncology Branch - Bethesda
Florida
- University of Miami - Miami
- All Children's Hospital - St. Petersburg
Michigan
- C.S. Mott Children's Hospital - Ann Arbor
- CS Mott Children's Hospital, Ann Arbor - Ann Arbor
New York
- New York University Medical Center - New York
- Children's Hospital New York-Presbyterian - New York
Colorado
- The Children's Hospital, University of Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta, Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-07-11 |
| Est. Completion | 2022-02-10 |
| Phase | Phase 1 |
What the finished NCT03263936 record still lists
NCT03263936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT03263936 names 20 study sites across 13 states, led by California, Maryland, Florida.
Frequently Asked Questions
What is clinical trial NCT03263936 about?
NCT03263936 is a clinical study titled "Epigenetic Reprogramming in Relapse/Refractory AML". This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).
What is the current status of trial NCT03263936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2017-07-11. Estimated completion is 2022-02-10.
What conditions does trial NCT03263936 study?
This clinical trial studies the following conditions: Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT03263936?
The interventions under investigation include: Fludarabine (DRUG), Decitabine (DRUG), Cytarabine (DRUG), Vorinostat (DRUG), Filgrastim (G-CSF) (DRUG).
Who is sponsoring clinical trial NCT03263936?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03263936 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03263936's enrollment target sits among peer trials
37 20th of 38 higher than 19 of 38 other Acute Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myelogenous 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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