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NCT04158739 · ClinicalTrials.gov registry record · Phase 1
Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 19
- Study locations
NCT04158739: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Children's Oncology Group.
NCT04158739 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 16 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04158739, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 19
- Study locations
Study Summary
This phase I trial studies the side effects, best dose of flotetuzumab and how well it works in treating patients with acute myeloid leukemia (AML) that has come back (recurrent) or has not responded to treatment (refractory). This study also determines the safest dose of flotetuzumab to use in children with AML. As an immunotherapy, flotetuzumab may also cause changes in the body's normal immune system, which are also under study in this trial.
Primary Outcome
Number and percentage of patients experiencing dose limiting toxicities during cycle 1 that are possibly, probably, or definitely due to flotetuzumab by dose level and study part.
Conditions Studied
Interventions
- DRUG Cytarabine
- BIOLOGICAL Flotetuzumab
Study Locations (19)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- UCSF Medical Center-Mission Bay - San Francisco
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04158739 still lists
NCT04158739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Cytarabine is the first listed.
NCT04158739 lists 19 locations in 16 states (California, Pennsylvania, Alabama).
Frequently Asked Questions
What is clinical trial NCT04158739 about?
NCT04158739 is a clinical study titled "Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia". This phase I trial studies the side effects, best dose of flotetuzumab and how well it works in treating patients with acute myeloid leukemia (AML) that has come back (recurrent) or has not responded to treatment (refractory). This study also determines the safest dose of flotetuzumab to use in chil...
What is the current status of trial NCT04158739?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-01-22. Estimated completion is 2026-03-31.
What conditions does trial NCT04158739 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04158739?
The interventions under investigation include: Cytarabine (DRUG), Flotetuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04158739?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158739 being conducted?
This trial has 19 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Acute Myeloid Leukemia
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Where NCT04158739's enrollment target sits among peer trials
16 54th of 63 higher than 10 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.
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