A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
NCT05828069
This study is recruiting at 101 US sites in 38 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Recurrent Langerhans Cell Histiocytosis
- Refractory Langerhans Cell Histiocytosis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 180 days to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- National Cancer Institute (NCI)
- Last updated on ClinicalTrials.gov
- October 15, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- Children's Hospital of Alabama · Birmingham, AL
Arkansas · 1
- Arkansas Children's Hospital · Little Rock, AR
California · 9
- Kaiser Permanente Downey Medical Center · Downey, CA
- Loma Linda University Medical Center · Loma Linda, CA
- Miller Children's and Women's Hospital Long Beach · Long Beach, CA
- Children's Hospital Los Angeles · Los Angeles, CA
- Kaiser Permanente-Oakland · Oakland, CA
- UCSF Benioff Children's Hospital Oakland · Oakland, CA
- Children's Hospital of Orange County · Orange, CA
- Lucile Packard Children's Hospital Stanford University · Palo Alto, CA
- UCSF Medical Center-Mission Bay · San Francisco, CA
Colorado · 2
- Children's Hospital Colorado · Aurora, CO
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center · Denver, CO
Connecticut · 2
- Connecticut Children's Medical Center · Hartford, CT
- Yale University · New Haven, CT
Delaware · 1
- Alfred I duPont Hospital for Children · Wilmington, DE
District of Columbia · 1
- Children's National Medical Center · Washington D.C., DC
Florida · 10
- Golisano Children's Hospital of Southwest Florida · Fort Myers, FL
- UF Health Cancer Institute - Gainesville · Gainesville, FL
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital · Hollywood, FL
- Nemours Children's Clinic-Jacksonville · Jacksonville, FL
- Nicklaus Children's Hospital · Miami, FL
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL
- Arnold Palmer Hospital for Children · Orlando, FL
- Nemours Children's Hospital · Orlando, FL
- Johns Hopkins All Children's Hospital · St. Petersburg, FL
- Saint Joseph's Hospital/Children's Hospital-Tampa · Tampa, FL
Georgia · 2
- Children's Healthcare of Atlanta - Arthur M Blank Hospital · Atlanta, GA
- Memorial Health University Medical Center · Savannah, GA
Hawaii · 1
- Kapiolani Medical Center for Women and Children · Honolulu, HI
Illinois · 3
- Lurie Children's Hospital-Chicago · Chicago, IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL
- OSF Children's Hospital of Illinois · Peoria, IL
Indiana · 1
- Riley Hospital for Children · Indianapolis, IN
Iowa · 2
- Blank Children's Hospital · Des Moines, IA
- University of Iowa/Holden Comprehensive Cancer Center · Iowa City, IA
Kentucky · 1
- University of Kentucky/Markey Cancer Center · Lexington, KY
Louisiana · 2
- Children's Hospital New Orleans · New Orleans, LA
- Ochsner Medical Center Jefferson · New Orleans, LA
Maryland · 2
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD
- Sinai Hospital of Baltimore · Baltimore, MD
Michigan · 2
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital · Grand Rapids, MI
- Bronson Methodist Hospital · Kalamazoo, MI
Minnesota · 1
- Children's Hospitals and Clinics of Minnesota - Minneapolis · Minneapolis, MN
Mississippi · 1
- University of Mississippi Medical Center · Jackson, MS
Missouri · 3
- Cardinal Glennon Children's Medical Center · St Louis, MO
- Mercy Hospital Saint Louis · St Louis, MO
- Washington University School of Medicine · St Louis, MO
Nebraska · 2
- Children's Hospital and Medical Center of Omaha · Omaha, NE
- University of Nebraska Medical Center · Omaha, NE
Nevada · 2
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation · Las Vegas, NV
- Summerlin Hospital Medical Center · Las Vegas, NV
New Jersey · 3
- Hackensack University Medical Center · Hackensack, NJ
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital · New Brunswick, NJ
- Saint Joseph's Regional Medical Center · Paterson, NJ
New York · 10
- Albany Medical Center · Albany, NY
- Maimonides Medical Center · Brooklyn, NY
- The Steven and Alexandra Cohen Children's Medical Center of New York · New Hyde Park, NY
- Laura and Isaac Perlmutter Cancer Center at NYU Langone · New York, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- Mount Sinai Hospital · New York, NY
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center · New York, NY
- NYP/Weill Cornell Medical Center · New York, NY
- State University of New York Upstate Medical University · Syracuse, NY
- Montefiore Medical Center - Moses Campus · The Bronx, NY
North Carolina · 4
- Mission Hospital · Asheville, NC
- Duke University Medical Center · Durham, NC
- East Carolina University · Greenville, NC
- Wake Forest University Health Sciences · Winston-Salem, NC
Ohio · 3
- Rainbow Babies and Childrens Hospital · Cleveland, OH
- Nationwide Children's Hospital · Columbus, OH
- Dayton Children's Hospital · Dayton, OH
Oklahoma · 1
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Oregon · 1
- Oregon Health and Science University · Portland, OR
Pennsylvania · 4
- Geisinger Medical Center · Danville, PA
- Children's Hospital of Philadelphia · Philadelphia, PA
- Saint Christopher's Hospital for Children · Philadelphia, PA
- Children's Hospital of Pittsburgh of UPMC · Pittsburgh, PA
South Carolina · 2
- Prisma Health Richland Hospital · Columbia, SC
- BI-LO Charities Children's Cancer Center · Greenville, SC
South Dakota · 1
- Sanford USD Medical Center - Sioux Falls · Sioux Falls, SD
Tennessee · 3
- East Tennessee Childrens Hospital · Knoxville, TN
- The Children's Hospital at TriStar Centennial · Nashville, TN
- Vanderbilt University/Ingram Cancer Center · Nashville, TN
Texas · 8
- Dell Children's Medical Center of Central Texas · Austin, TX
- UT Southwestern/Simmons Cancer Center-Dallas · Dallas, TX
- El Paso Children's Hospital · El Paso, TX
- UT MD Anderson Cancer Center · Houston, TX
- Children's Hospital of San Antonio · San Antonio, TX
- Methodist Children's Hospital of South Texas · San Antonio, TX
- University of Texas Health Science Center at San Antonio · San Antonio, TX
- Scott and White Memorial Hospital · Temple, TX
Utah · 1
- Primary Children's Hospital · Salt Lake City, UT
Virginia · 3
- University of Virginia Cancer Center · Charlottesville, VA
- Children's Hospital of The King's Daughters · Norfolk, VA
- VCU Massey Comprehensive Cancer Center · Richmond, VA
Washington · 2
- Seattle Children's Hospital · Seattle, WA
- Providence Sacred Heart Medical Center and Children's Hospital · Spokane, WA
West Virginia · 1
- Vandalia Health/CAMC Institute for Academic Medicine · Charleston, WV
Wisconsin · 2
- Saint Vincent Hospital Cancer Center Green Bay · Green Bay, WI
- Children's Hospital of Wisconsin · Milwaukee, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.