NCT02523040

Lenalidomide for Adult Histiocyte Disorders

A Phase II Study of Lenalidomide for Adult Histiocyte Disorders

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a chemotherapy drug Lenalidomide as a possible treatment for one of three histiocyte disorders: Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), or histiocytic sarcoma (HS).

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved lenalidomide for your specific disease but it has been approved for other uses. Lenalidomide is a chemotherapy drug that belongs to a class of drugs called immunomodulatory drugs (IMiDs), which modify a participant's immune response in order to treat cancer. Lenalidomide alters the body's immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, it may reduce or prevent the growth of cancer cells. Lenalidomide has been shown to restore the immune cells' ability to attack and kill tumor cells Lenalidomide is approved by the FDA to treat certain cancers including multiple myeloma and myelodysplastic syndrome.

Conditions

• Langerhans Cell Histiocytosis (LCH)
• Histiocytoses Erdheim-chester Disease
• Histiocytic Sarcoma (HS)

Interventions

Type	Name	Description
DRUG	Lenalidomide

Timeline

• Start date: 2015-08-01
• Primary completion: 2024-02-01
• Completion: 2026-02-01
• First posted: 2015-08-14
• Last updated: 2025-12-10
• Results posted: 2025-04-25

Locations

1 site across 1 country: United States