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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate

Secondary outcome measures

Number of Participating with Grade 3-4 toxicity

Overall Survival

Progression Free Survival (PFS)

+3 more

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

~1480

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,860 Total Patients Enrolled

1 Trials studying Histiocytic Sarcoma

18 Patients Enrolled for Histiocytic Sarcoma

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,959 Total Patients Enrolled

Eric Jacobsen, MDPrincipal InvestigatorDana-Farber Cancer Institute

5 Previous Clinical Trials

141 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for this experiment?

"This particular clinical trial is no longer seeking patients, according to the most recent information available on clinicaltrials.gov. The study was initially posted on 8/1/2015, and though it has since been edited (8/26/2022), patient recruitment has ceased. Having said that, there are still 750 other trials which are actively recruiting patients."

Answered by AI

How many people can potentially join this research project?

"This study is no longer recruiting patients. The 8/26/2022 edit to the trial's posting was the most recent one. 477 other trials are currently looking for patients with erdheim-chester disease and 273 trials involving Lenalidomide are actively enrolling patients."

Answered by AI

Has the Federal Drug Administration cleared lenalidomide for use?

"While there is some evidence to support the safety of Lenalidomide, it only received a score of 2 because this is classified as a Phase 2 trial. This means that while there are studies indicating that Lenalidomide is safe, none have been done to test its efficacy."

Answered by AI