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

PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 28, 2024

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Recurrent Langerhans Cell HistiocytosisRefractory Langerhans Cell Histiocytosis
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood and urine samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

FDG-Positron Emission Tomography and Computed Tomography Scan

Undergo FDG-PET imaging

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Tovorafenib

Given PO

Trial Locations (108)

2031

RECRUITING

Sydney Children's Hospital, Randwick

4101

RECRUITING

Queensland Children's Hospital, South Brisbane

6009

RECRUITING

Perth Children's Hospital, Perth

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10032

RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

RECRUITING

NYP/Weill Cornell Medical Center, New York

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

10595

RECRUITING

New York Medical College, Valhalla

11040

RECRUITING

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

11219

RECRUITING

Maimonides Medical Center, Brooklyn

12208

RECRUITING

Albany Medical Center, Albany

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17822

RECRUITING

Geisinger Medical Center, Danville

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19134

RECRUITING

Saint Christopher's Hospital for Children, Philadelphia

19803

RECRUITING

Alfred I duPont Hospital for Children, Wilmington

20010

RECRUITING

Children's National Medical Center, Washington D.C.

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

23507

RECRUITING

Children's Hospital of The King's Daughters, Norfolk

25304

RECRUITING

West Virginia University Charleston Division, Charleston

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27710

RECRUITING

Duke University Medical Center, Durham

27834

RECRUITING

East Carolina University, Greenville

28801

RECRUITING

Mission Hospital, Asheville

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

29605

RECRUITING

BI-LO Charities Children's Cancer Center, Greenville

30329

RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

31404

RECRUITING

Memorial Health University Medical Center, Savannah

32207

RECRUITING

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

32827

RECRUITING

Nemours Children's Hospital, Orlando

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33155

RECRUITING

Nicklaus Children's Hospital, Miami

33607

RECRUITING

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33908

RECRUITING

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

RECRUITING

Children's Hospital of Alabama, Birmingham

37203

RECRUITING

The Children's Hospital at TriStar Centennial, Nashville

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

37916

RECRUITING

East Tennessee Childrens Hospital, Knoxville

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

43205

RECRUITING

Nationwide Children's Hospital, Columbus

44106

RECRUITING

Rainbow Babies and Childrens Hospital, Cleveland

45404

RECRUITING

Dayton Children's Hospital, Dayton

46202

RECRUITING

Riley Hospital for Children, Indianapolis

48823

SUSPENDED

Michigan State University, East Lansing

49007

RECRUITING

Bronson Methodist Hospital, Kalamazoo

49503

RECRUITING

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

50309

RECRUITING

Blank Children's Hospital, Des Moines

52242

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

RECRUITING

Children's Hospital of Wisconsin, Milwaukee

55404

RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

55455

RECRUITING

University of Minnesota/Masonic Cancer Center, Minneapolis

60611

RECRUITING

Lurie Children's Hospital-Chicago, Chicago

60637

RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

61637

RECRUITING

Saint Jude Midwest Affiliate, Peoria

63104

RECRUITING

Cardinal Glennon Children's Medical Center, St Louis

63110

RECRUITING

Washington University School of Medicine, St Louis

63141

RECRUITING

Mercy Hospital Saint Louis, St Louis

68114

RECRUITING

Children's Hospital and Medical Center of Omaha, Omaha

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70118

RECRUITING

Children's Hospital New Orleans, New Orleans

70121

RECRUITING

Ochsner Medical Center Jefferson, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

75390

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76508

RECRUITING

Scott and White Memorial Hospital, Temple

77030

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

RECRUITING

M D Anderson Cancer Center, Houston

78207

RECRUITING

Children's Hospital of San Antonio, San Antonio

78229

RECRUITING

Methodist Children's Hospital of South Texas, San Antonio

RECRUITING

University of Texas Health Science Center at San Antonio, San Antonio

78723

RECRUITING

Dell Children's Medical Center of Central Texas, Austin

79905

RECRUITING

El Paso Children's Hospital, El Paso

80045

RECRUITING

Children's Hospital Colorado, Aurora

80218

RECRUITING

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

89135

RECRUITING

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas

89144

RECRUITING

Summerlin Hospital Medical Center, Las Vegas

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

90242

RECRUITING

Kaiser Permanente Downey Medical Center, Downey

92354

RECRUITING

Loma Linda University Medical Center, Loma Linda

92868

RECRUITING

Children's Hospital of Orange County, Orange

93636

RECRUITING

Valley Children's Hospital, Madera

94158

RECRUITING

UCSF Medical Center-Mission Bay, San Francisco

94304

RECRUITING

Lucile Packard Children's Hospital Stanford University, Palo Alto

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

94611

RECRUITING

Kaiser Permanente-Oakland, Oakland

97239

RECRUITING

Oregon Health and Science University, Portland

98105

RECRUITING

Seattle Children's Hospital, Seattle

99204

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

72202-3591

RECRUITING

Arkansas Children's Hospital, Little Rock

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

06520

RECRUITING

Yale University, New Haven

07601

RECRUITING

Hackensack University Medical Center, Hackensack

08903

RECRUITING

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

07503

RECRUITING

Saint Joseph's Regional Medical Center, Paterson

T6G 2B7

RECRUITING

University of Alberta Hospital, Edmonton

B3K 6R8

RECRUITING

IWK Health Centre, Halifax

L8N 3Z5

RECRUITING

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

N6A 5W9

RECRUITING

Children's Hospital, London

M5G 1X8

RECRUITING

Hospital for Sick Children, Toronto

H3T 1C5

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

G1V 4G2

RECRUITING

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Québec

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH