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Immunomodulatory Agent
Chemotherapy for Histiocytosis
Phase 2
Waitlist Available
Led By Eric Jacobsen, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2 (Karnofsky ≥60%)
Patients with LCH must require systemic therapy according to the Histiocyte Society LCH Evaluation and Treatment Guidelines (HS 2009) or patients with HS requiring systemic treatment as defined by disease that cannot be surgically resected and/or encompassed in a single radiation field
Must not have
Prior treatment with lenalidomide
History of another invasive malignancy unless treated with curative intent 5 years or more prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a chemotherapy drug, Lenalidomide, as a possible treatment for three different histiocyte disorders: Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), or histiocytic sarcoma (HS).
Who is the study for?
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.
What is being tested?
The trial is testing Lenalidomide as a potential chemotherapy treatment for three types of histiocyte disorders. It aims to see how effective it is in treating these diseases by monitoring participants' responses to the drug.
What are the potential side effects?
Lenalidomide may cause blood clots, fatigue, diarrhea, itching/rash, nausea/vomiting; it can also affect blood counts leading to anemia or increased risk of infection. Some people might experience dizziness or coughing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do active work.
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I have LCH or HS that needs treatment beyond surgery or localized radiation.
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I am 18 years old or older.
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My blood counts and liver/kidney functions are within normal ranges.
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I can take daily aspirin if I'm not already on certain blood thinners.
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I am registered and can follow the Revlimid REMS program requirements.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with lenalidomide before.
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I had cancer before, but it was treated over 5 years ago.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I am not pregnant or breastfeeding.
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I am HIV-positive and on combination antiretroviral therapy.
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I cannot swallow pills.
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I have an active hepatitis B or C infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LenalidomideExperimental Treatment1 Intervention
After the screening procedures confirm participation in the research study.
- Lenalidomide Oral, Daily for 21 days of each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,225 Total Patients Enrolled
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,420 Total Patients Enrolled
Eric Jacobsen, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with lenalidomide before.I can care for myself but may not be able to do active work.I had cancer before, but it was treated over 5 years ago.You have a disease that can be seen on a CT scan, PET scan, bone scan, or MRI.I am not pregnant or breastfeeding.I am 18 years old or older.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am HIV-positive and on combination antiretroviral therapy.I have been on a stable dose of ≤10 mg daily prednisone or equivalent for at least 2 weeks.My condition is confirmed as LCH, ECD, or HS.I have LCH or HS that needs treatment beyond surgery or localized radiation.My blood counts and liver/kidney functions are within normal ranges.I can take daily aspirin if I'm not already on certain blood thinners.I am registered and can follow the Revlimid REMS program requirements.I haven't had chemotherapy or radiation in the last 2 weeks, or 6 weeks for specific drugs, and have recovered from any side effects.I cannot swallow pills.I agree to use birth control during the study.I have an active hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Lenalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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