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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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

~1340

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,100 Previous Clinical Trials

353,085 Total Patients Enrolled

1 Trials studying Histiocytic Sarcoma

18 Patients Enrolled for Histiocytic Sarcoma

CelgeneIndustry Sponsor

645 Previous Clinical Trials

130,537 Total Patients Enrolled

Eric Jacobsen, MDPrincipal InvestigatorDana-Farber Cancer Institute

5 Previous Clinical Trials

125 Total Patients Enrolled

1 Trials studying Histiocytic Sarcoma

18 Patients Enrolled for Histiocytic Sarcoma

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02523040 — Phase 2

Histiocytic Sarcoma Research Study Groups: Lenalidomide

Histiocytic Sarcoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT02523040 — Phase 2

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02523040 — Phase 2

~1 spots leftby Sep 2025

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