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NCT05828069 · ClinicalTrials.gov registry record · Phase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
A Phase 2 study of Recurrent Langerhans Cell Histiocytosis and Refractory Langerhans Cell Histiocytosis, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05828069: Recruiting Phase 2 study of Recurrent Langerhans Cell Histiocytosis and Refractory Langerhans Cell Histiocytosis, sponsored by National Cancer Institute (NCI).
NCT05828069 is a Phase 2 study of Recurrent Langerhans Cell Histiocytosis and Refractory Langerhans Cell Histiocytosis that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, above the 15-participant average among 8 other Recurrent Langerhans Cell Histiocytosis trials with a reported enrollment target (220% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05828069, a Phase 2 study of Recurrent Langerhans Cell Histiocytosis and Refractory Langerhans Cell Histiocytosis, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
Primary Outcome
Will be analyzed descriptively.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - 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
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- UF Health Cancer Institute - Gainesville - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
What NCT05828069 shows while recruiting
NCT05828069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, above the 15-participant average among 8 other Recurrent Langerhans Cell Histiocytosis trials with a reported enrollment target (220% higher).
The record links to 2 conditions, with Recurrent Langerhans Cell Histiocytosis appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05828069 names 20 study sites across 8 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT05828069 about?
NCT05828069 is a clinical study titled "A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis". This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (re...
What is the current status of trial NCT05828069?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2024-03-28. Estimated completion is 2028-09-30.
What conditions does trial NCT05828069 study?
This clinical trial studies the following conditions: Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis.
What interventions are being tested in trial NCT05828069?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT05828069?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05828069 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05828069's enrollment target sits among peer trials
48 1st of 8 higher than 8 of 8 other Recurrent Langerhans Cell Histiocytosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Langerhans Cell Histiocytosis 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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