Clinical Trial: Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase I/II Study of Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R(2)) In Primary Effusion Lymphoma or KSHV-Associated Large Cell Lymphoma

Brief Summary:

Background:

Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers want to see if a drug called lenalidomide along with common chemotherapy drugs may be effective in treating PEL.

Objective:

To test a new treatment for PEL.

Eligibility:

People ages 18 and older with PEL.

Design:

Participants will be screened with blood tests, imaging studies, a physical exam, and other tests.

Participants will have tests to evaluate their disease. These may include:

Blood tests

Scans

Lumbar puncture. Fluid around the spinal cord will be removed with a needle.

Bone marrow removed with a needle and studied

Samples of skin or lymph nodes removed

Fluid removed from around organs

Lung and eye tests

Tubes with cameras taking pictures of airways or digestive tract

Participants will take lenalidomide pills for 10 days. They will keep a pill diary.

Participants will have a catheter (small tube) placed in the large vein in the arm or chest.

Participants will get DA-EPOCH-R as intra

Detailed Summary:

Background

  • Kaposi sarcoma herpesvirus (KSHV)-associated primary effusion lymphoma (PEL) is an aggressive B cell neoplasm with clinicopathologic and molecular profiles distinct from other AIDS-related lymphomas.
  • There are no prospective studies on these rare lymphomas. Clinical experience is limited; however, reported prognosis is poor, with median survival estimated at less than 6 months using conventional CHOP-like chemotherapy.
  • Novel treatment is urgently needed for KSHV-associated lymphomas, and the therapeutic approach must take into account concurrent KSHV-associated malignancies which are commonly seen in this patient population
  • Lenalidomide, an immune-modulatory derivative of thalidomide (IMiD drug) has in vitro direct antitumor effect in KSHV-lymphomas as well as immune modulatory and antiangiogenic effects that may be beneficial in treating PEL
  • Rituximab, an anti-CD20 monoclonal antibody, has recently been shown to be an active agent in the management of KSHV-MCD. Although PEL is a CD20-negative tumor, advances in the understanding the biology of KSHV-infection of B-cells, the pathobiology of IL-6 syndromes in KSHV-MCD and KSHV-NHL, and clinical experience using rituximab in the treatment of KSHV-MCD, support use of rituximab in the treatment of PEL, especially in patients with concurrent KSHV-MCD.
  • Modified dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA)-EPOCH is an anthracycline-based regimen that allows for personalization of dose-intensity showing that inclusion of etoposide and infusional administration decreases tumor cell resistance.
  • The use of DA-EPOCH in combination with rituxi
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome:

    • (Phase I) Maximum tolerated dose of DA-EPOCH_R2 [ Time Frame: End of two cycles of treatment ]
    • (Phase II) Overall survival in treatment-naive patients with primary effusion lymphoma treated with DA-EPOCH-R2 [ Time Frame: One year post end of treatment ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: September 21, 2016
    Date Started: September 15, 2016
    Date Completion: October 1, 2025
    Last Updated: May 13, 2017
    Last Verified: April 7, 2017