Study on Lenalidomide for Treating Adult Histiocyte Disorders

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02523040

Provider View

This clinical trial is exploring the use of the chemotherapy drug Lenalidomide as a potential treatment for adults with certain histiocyte disorders, including Langerhans cell histiocytosis, Erdheim-Chester disease, and histiocytic sarcoma.

Patient Parameters

Program Overview

The purpose of this study is to test if Lenalidomide, a chemotherapy drug, can be an effective treatment for adults with specific histiocyte disorders. These disorders include Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), and histiocytic sarcoma (HS). Lenalidomide is already approved for treating other types of cancer, but it is not yet approved for these specific conditions. The drug works by modifying the immune system and may help reduce or stop the growth of cancer cells by interfering with the blood vessels that support tumors.

Description

This is a Phase II clinical trial, which means it is focused on testing the safety and effectiveness of Lenalidomide for treating certain histiocyte disorders. Although Lenalidomide is not yet approved by the FDA for these specific conditions, it is approved for other cancers like multiple myeloma. The drug belongs to a group of medications called immunomodulatory drugs (IMiDs), which help the immune system fight cancer. Lenalidomide may also prevent the growth of new blood vessels that tumors need to grow, potentially reducing or stopping cancer cell growth. Participants in this study will receive Lenalidomide to see if it can help treat their condition.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), or histiocytic sarcoma (HS).
  • Must have detectable disease through scans like CT, PET, bone scan, or MRI.
  • Patients with LCH must need systemic therapy as per specific guidelines.
  • Patients with HS must need systemic treatment if the disease cannot be surgically removed or treated with radiation alone.
  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Must have normal organ and bone marrow function, as shown by specific blood test results.
  • Must be able to take a low-dose aspirin daily unless on other blood thinners.
  • Must be registered in the Revlimid REMS® program and agree to follow its requirements.
  • Women of childbearing potential and men must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have had chemotherapy or radiation within the last 2 weeks (or 6 weeks for certain drugs) before starting the study.
  • Are currently taking other experimental drugs.
  • Have been treated with Lenalidomide before.
  • Have another invasive cancer unless treated successfully over 5 years ago.
  • Have uncontrolled illnesses like active infections, heart failure, or psychiatric conditions that could interfere with the study.
  • Are pregnant or breastfeeding, as Lenalidomide can harm the baby.
  • Have active hepatitis B or C infections.
  • Are HIV-positive and on antiretroviral therapy, due to potential drug interactions and increased infection risk.
  • Are taking corticosteroids unless on a stable low dose for at least 2 weeks before starting the study.
  • Cannot swallow pills.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02115BostonMassachusetts

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