Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 19, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2029

Conditions
Langerhan's Cell HistiocytosisJuvenile XanthogranulomaErdheim-Chester DiseaseRosai Dorfman DiseaseNeuro-Degenerative DiseaseHistiocytic SarcomaHistiocytic Disorders, Malignant
Interventions
DRUG

Cobimetinib

Cobimetinib will be administered at a maximal dose of 60 mg daily for patients \<18 years old and a flat dose of 40 mg daily for patients ≥18 years for 21 days on, then 7 days off, in a 28-day treatment cycle for a total of 12 cycles (approximately 12 months).

Trial Locations (12)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

20010

RECRUITING

Children's National Hospital, Washington D.C.

21287

RECRUITING

John Hopkins University School of Medicine, Baltimore

38105

NOT_YET_RECRUITING

NACHO Consortium, Memphis

53792

TERMINATED

University of Wisconsin-American Family Children's Hospital, Madison

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

75235

RECRUITING

Children's Medical Center- UTSW, Dallas

77030

RECRUITING

Texas Children's Hospital, Houston

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

92868

RECRUITING

Children's Hospital of Orange County, Orange

94158

RECRUITING

UCSF Benioff Children's Hospital, San Francisco

02215

RECRUITING

Dana Farber Cancer Institute, Boston Children's, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

collaborator

North American Consortium for Histiocytosis

OTHER

collaborator

Genentech, Inc.

INDUSTRY

lead

Carl Allen

OTHER