drugset / Trial / NCT04120519

Thalidomide, Cyclophosphamide and Dexamethasone for Recurrent/Refractory Adult Langerhans Cell Histiocytosis

NCT04120519 ↗

Phase 2 Unknown 20 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

Summary

Langerhans cell histiocytosis (LCH) is a rare, heterogeneous histiocytic disorder occurring most commonly in children. Because of the rarity of LCH in adults and a lack of prospective randomized trials, the treatment strategy for adults is mostly based on pediatric protocols. The overall response rate of therapy based on vinblastine plus prednisone in adults is lower than in children and the treatment tends to show higher toxicity.There is little data to guide therapy after frontline treatment. In a phase 2 trial, thalidomide as monotherapy gave a 70% response rate in recurrent/refractory low risk LCH but there were no responses in six high risk children. We want to analyze the efficacy and toxicity of thalidomide combined with dexamethasone and cyclophosphamide regimens in the treatment of recurrent/refractory LCH among adult patients at our hospital.

Timeline

Start
2019-10-10
Primary completion
2021-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 300 mg/m2 —
Subject Dexamethasone Small molecule 40 mg —
Subject Thalidomide Other / unclassified 100 mg —