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 May 6, 2026, 8:11 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

Study identification

NCT ID: NCT05828069
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 48 participants

Conditions and interventions

Conditions

Interventions

Biospecimen Collection Procedure
Bone Marrow Aspiration Procedure
Bone Marrow Biopsy Procedure
Computed Tomography Procedure
Echocardiography Test Procedure
FDG-Positron Emission Tomography and Computed Tomography Scan Procedure
Lumbar Puncture Procedure
Multigated Acquisition Scan Procedure
Tovorafenib Drug

Procedure · Drug

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: May 5, 2026

2024 – 2028

United States locations

U.S. sites: 104
U.S. states: 38
U.S. cities: 85

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
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
Saint Jude Midwest Affiliate	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
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	Suspended
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	Recruiting
New York Medical College	Valhalla	New York	10595	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	Recruiting
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	Suspended
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	Suspended
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	77030	Recruiting
M D 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
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 May 5, 2026 · Synced May 6, 2026

Open the official record

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

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