Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
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Clinical Trial Information
Trial Contact: Parker, Melanie; Armatti, Julie M; Torrescano, Tanner; Frankos, Marie; Singh, Sarah H; Jones, Jamie
Trial Phone: 321-843-1036 ; 321-843-5284 ; 321-841-8271 ; 321-842-8738 ; 321.841.7561 ; 3218412008
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IRB No: ANHL2121
Protocol Abbrev: ANHL2121
Principal Investigator: Jaime A. Carvajal, MD
Phase: Drug: Phase II
Age Group: Pediatric
Treatment: Procedure: 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, Drug: Tovorafenib
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05828069
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Objective
To determine overall response rate (ORR) for children and young adults with relapsed or refractory Langerhans cell histiocytosis (LCH) treated with tovorafenib (DAY101) after 2 cycles and must be maintained 4 weeks later.
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Key Eligibility
180 days- < 22 years (at time of study enrollment)
Patient must have a body surface area of ≥ 0.3 m^2
Patients with progressive, relapsed, or recurrent LCH with measurable disease at study entry
