A Study of Lenalidomide for Adult Histiocyte Disorders
|ClinicalTrials.gov Identifier: NCT02523040|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : October 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Langerhans Cell Histiocytosis (LCH) Histiocytoses Erdheim-chester Disease Histiocytic Sarcoma (HS)||Drug: Lenalidomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenalidomide for Adult Histiocyte Disorders|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2022|
After the screening procedures confirm participation in the research study.
- Lenalidomide Oral, Daily for 21 days of each cycle
Other Name: Revlimid
- Response Rate [ Time Frame: 12 Months ]
- Progression Free Survival (PFS) [ Time Frame: 12 Months ]
- Overall Survival [ Time Frame: 12 Months ]
- Number of Participating with Grade 3-4 toxicity [ Time Frame: 12 Months ]
- Quantitative serial measurements of urine cell free DNA for BRAF mutation as a biomarker of response [ Time Frame: 12 Months ]
- Quantitative serial measurements of serum TNF-alpha levels as a biomarker of response [ Time Frame: 12 Months ]
- Quantitative serial measurements of plasma cell free DNA for BRAF mutation as a biomarker of response [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523040
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Eric Jacobsen, MD||Dana-Farber Cancer Institute|