Study on Daratumumab for Treating Relapsed or Hard-to-Treat Primary Effusion Lymphoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05907759

Provider View

This clinical trial is testing the drug daratumumab for people with primary effusion lymphoma (PEL) that has not responded to previous treatments or who cannot receive standard treatments. The study aims to see if daratumumab can help control the disease.

Patient Parameters

Program Overview

Primary effusion lymphoma (PEL) is a rare and aggressive cancer affecting the immune system and lymph nodes. It is difficult to treat with standard therapies. This study is testing a drug called daratumumab, given as an injection under the skin, to see if it can help people with PEL whose disease has returned or is resistant to other treatments. Participants will receive the drug weekly for 8 weeks, then every 2 weeks for 16 weeks, and finally every 4 weeks for up to 2 years. The study will include regular check-ups and tests to monitor the participants' health and the drug's effects.

Description

Primary effusion lymphoma (PEL) is a type of cancer that affects the immune system and is linked to a virus called Kaposi sarcoma herpesvirus (KSHV). It is a challenging disease to treat, especially when it does not respond to initial treatments. This study is exploring the use of daratumumab, a drug that targets specific cancer cells, to see if it can help people with PEL who have not had success with other treatments.

Participants in the study will receive daratumumab as an injection under the skin in the abdomen. The treatment schedule involves weekly injections for the first 8 weeks, followed by injections every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months. Throughout the study, participants will undergo various tests, including blood tests, imaging scans, and possibly procedures like lumbar punctures or thoracentesis, to monitor their health and the treatment's effectiveness.

The study will also include follow-up visits after the treatment ends, and participants will be involved in the study for up to 5 years. The goal is to determine if daratumumab can improve outcomes for people with relapsed or hard-to-treat PEL.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of primary effusion lymphoma (PEL) that has returned or is resistant to treatment, or be unable to receive standard chemotherapy.
  • Any HIV status is allowed, but those with HIV must have a certain level of immune cells and be on or willing to start antiretroviral therapy.
  • Must have measurable or assessable lymphoma.
  • Have a performance status score of 0 to 3, indicating varying levels of activity and ability to perform daily tasks.
  • Have adequate blood and kidney function.
  • Women of childbearing potential must agree to use effective contraception during the study and for 3 months after.
  • Men must agree to use effective contraception during the study and for 3 months after.
  • Must be willing to stop breastfeeding during the study and for 3 months after.
  • Must understand and sign a consent form to participate.

Exclusion Criteria

  • Have had cancer treatment within the last 2 weeks, unless it is for a condition that does not interfere with the study.
  • Require urgent treatment for Kaposi sarcoma.
  • Have high levels of bilirubin or liver enzymes, unless due to specific conditions.
  • Have low blood cell counts unless related to lymphoma or prior treatment.
  • Have life-threatening symptoms of KSHV-MCD.
  • Have significant heart disease or uncontrolled heart conditions.
  • Have severe lung disease or uncontrolled asthma.
  • Be pregnant or have a positive pregnancy test.
  • Have severe uncontrolled illnesses not related to lymphoma.

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