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Recruiting Phase 2 Interventional

A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

ClinicalTrials.gov ID: NCT05828069

Public ClinicalTrials.gov record NCT05828069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 9:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05828069
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
48 participants

Conditions and interventions

Eligibility (public fields only)

Age range
180 Days to 22 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 27, 2024
Primary completion
Sep 29, 2028
Completion
Sep 29, 2028
Last update posted
Sep 7, 2026

2024 – 2028

United States locations

U.S. sites
107
U.S. states
38
U.S. cities
87
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 Recruiting
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 Recruiting
Kaiser Permanente Downey Medical Center Downey California 90242 Recruiting
Loma Linda University Medical Center Loma Linda California 92354 Recruiting
Miller Children's and Women's Hospital Long Beach Long Beach California 90806 Recruiting
Children's Hospital Los Angeles Los Angeles California 90027 Recruiting
Valley Children's Hospital Madera California 93636 Active, not recruiting
UCSF Benioff Children's Hospital Oakland Oakland California 94609 Recruiting
Kaiser Permanente-Oakland Oakland California 94611 Recruiting
Children's Hospital of Orange County Orange California 92868 Recruiting
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304 Recruiting
UCSF Medical Center-Mission Bay San Francisco California 94158 Recruiting
Children's Hospital Colorado Aurora Colorado 80045 Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
Yale University New Haven Connecticut 06520 Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware 19803 Recruiting
Children's National Medical Center Washington D.C. District of Columbia 20010 Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida 32610 Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida 33021 Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 Recruiting
Nicklaus Children's Hospital Miami Florida 33155 Recruiting
Arnold Palmer Hospital for Children Orlando Florida 32806 Recruiting
Nemours Children's Hospital Orlando Florida 32827 Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 Recruiting
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida 33607 Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 Recruiting
Memorial Health University Medical Center Savannah Georgia 31404 Recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 Recruiting
Lurie Children's Hospital-Chicago Chicago Illinois 60611 Recruiting
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637 Recruiting
OSF Children's Hospital of Illinois Peoria Illinois 61637 Recruiting
Riley Hospital for Children Indianapolis Indiana 46202 Recruiting
Blank Children's Hospital Des Moines Iowa 50309 Recruiting
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 Recruiting
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 Recruiting
Children's Hospital New Orleans New Orleans Louisiana 70118 Recruiting
Ochsner Medical Center Jefferson New Orleans Louisiana 70121 Recruiting
Sinai Hospital of Baltimore Baltimore Maryland 21215 Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 Recruiting
Michigan State University East Lansing Michigan 48823 Suspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 Recruiting
Bronson Methodist Hospital Kalamazoo Michigan 49007 Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 Recruiting
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455 Active, not recruiting
University of Mississippi Medical Center Jackson Mississippi 39216 Recruiting
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Mercy Hospital Saint Louis St Louis Missouri 63141 Recruiting
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114 Recruiting
University of Nebraska Medical Center Omaha Nebraska 68198 Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada 89135 Recruiting
Summerlin Hospital Medical Center Las Vegas Nevada 89144 Recruiting
Hackensack University Medical Center Hackensack New Jersey 07601 Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey 08903 Recruiting
Saint Joseph's Regional Medical Center Paterson New Jersey 07503 Recruiting
Albany Medical Center Albany New York 12208 Recruiting
Maimonides Medical Center Brooklyn New York 11219 Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040 Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016 Recruiting
Mount Sinai Hospital New York New York 10029 Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
NYP/Weill Cornell Medical Center New York New York 10065 Recruiting
State University of New York Upstate Medical University Syracuse New York 13210 Recruiting
Montefiore Medical Center - Moses Campus The Bronx New York 10467 Suspended
New York Medical College Valhalla New York 10595 Active, not recruiting
Mission Hospital Asheville North Carolina 28801 Recruiting
Duke University Medical Center Durham North Carolina 27710 Recruiting
East Carolina University Greenville North Carolina 27834 Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Recruiting
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Dayton Children's Hospital Dayton Ohio 45404 Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 Recruiting
Oregon Health and Science University Portland Oregon 97239 Recruiting
Geisinger Medical Center Danville Pennsylvania 17822 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Suspended
Saint Christopher's Hospital for Children Philadelphia Pennsylvania 19134 Recruiting
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 Recruiting
Prisma Health Richland Hospital Columbia South Carolina 29203 Recruiting
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605 Recruiting
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 Recruiting
East Tennessee Childrens Hospital Knoxville Tennessee 37916 Recruiting
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203 Recruiting
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 Recruiting
Dell Children's Medical Center of Central Texas Austin Texas 78723 Recruiting
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 Recruiting
El Paso Children's Hospital El Paso Texas 79905 Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030 Recruiting
UT MD Anderson Cancer Center Houston Texas 77030 Recruiting
Children's Hospital of San Antonio San Antonio Texas 78207 Recruiting
Methodist Children's Hospital of South Texas San Antonio Texas 78229 Recruiting
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 Recruiting
Scott and White Memorial Hospital Temple Texas 76508 Recruiting
Primary Children's Hospital Salt Lake City Utah 84113 Recruiting
University of Virginia Cancer Center Charlottesville Virginia 22908 Recruiting
Children's Hospital of The King's Daughters Norfolk Virginia 23507 Recruiting
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 Recruiting
Seattle Children's Hospital Seattle Washington 98105 Recruiting
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 Recruiting
West Virginia University Charleston Division Charleston West Virginia 25304 Recruiting
Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin 54301 Recruiting
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05828069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05828069 live on ClinicalTrials.gov.

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