Chemotherapy for Histiocytosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a chemotherapy drug called Lenalidomide to determine its effectiveness in treating certain rare diseases known as histiocytic disorders. These disorders include Langerhans cell histiocytosis, Erdheim-Chester disease, and histiocytic sarcoma, where the body produces too many immune cells. Individuals with these conditions who require systemic treatment may be suitable candidates. Participants must be able to take aspirin as part of the trial and must not have received certain treatments recently. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on other investigational drugs or certain HIV treatments. If you're on corticosteroids, you must be on a stable low dose for at least 2 weeks before starting the study drug.
Is there any evidence suggesting that Lenalidomide is likely to be safe for humans?
Research has shown that lenalidomide is generally well-tolerated by patients. In studies involving individuals with Rosai-Dorfman disease, lenalidomide combined with another drug proved to be safe, with most patients experiencing no serious side effects. Some reported mild issues such as nausea, vomiting, and diarrhea, which are common with many medications.
Another study found that lenalidomide benefited people with Langerhans cell histiocytosis (LCH), a disorder similar to the one being studied in this trial, and it was also considered safe. While some individuals might experience mild side effects, previous research indicates that the drug is generally safe.
These findings suggest that lenalidomide is a promising option for the conditions under study in this trial. However, participants should always discuss potential risks with the study team before joining any trial.12345Why do researchers think this study treatment might be promising for histiocytosis?
Lenalidomide is unique because it offers a novel approach to treating histiocytosis by modulating the immune system. Unlike standard treatments that often focus on chemotherapy or targeted therapies, lenalidomide works by enhancing the immune response and inhibiting the growth of abnormal cells. Researchers are excited about lenalidomide because it has the potential to be more selective in targeting diseased cells, possibly leading to fewer side effects and improved outcomes for patients. This new mechanism of action represents a promising alternative to existing options.
What evidence suggests that Lenalidomide might be an effective treatment for histiocytosis?
Research has shown that Lenalidomide, the treatment under study in this trial, yields promising results for certain histiocyte disorders. In Langerhans cell histiocytosis (LCH), Lenalidomide has demonstrated potential, particularly in cases unresponsive to standard treatments. Studies have highlighted its effectiveness and safety, offering hope to patients seeking new options. Additionally, in Rosai-Dorfman disease, Lenalidomide achieved an overall response rate of 87%, indicating strong potential for success in similar conditions. These findings support ongoing research into Lenalidomide for treating histiocytic disorders like LCH, Erdheim-Chester disease (ECD), and histiocytic sarcoma (HS).14567
Who Is on the Research Team?
Eric Jacobsen, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Adults over 18 with Langerhans cell histiocytosis, Erdheim-Chester disease, or histiocytic sarcoma needing systemic therapy can join. They must have good organ function and performance status, confirmed diagnosis, detectable disease via scans, and be able to take daily aspirin unless on certain anticoagulants. Participants need to follow birth control guidelines and the Revlimid REMS program.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lenalidomide orally, daily for 21 days of each cycle, with disease assessed every 3 cycles up to 12 cycles
Follow-up
Participants are monitored for progression-free survival and overall survival, with assessments every 3 months for 2 years, then every 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Lenalidomide
Lenalidomide is already approved in European Union, United States for the following indications:
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Celgene
Industry Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania