Comparing the Effectiveness of Immunotherapy Drugs Rituximab and Mosunetuzumab in Patients with Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05886036

Provider View

This clinical trial is comparing two immunotherapy drugs, rituximab and mosunetuzumab, to see which one is better at helping patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) live longer without the cancer getting worse.

Patient Parameters

Program Overview

This study is testing whether mosunetuzumab, a new immunotherapy drug, is more effective than the usual treatment, rituximab, for patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Both drugs are designed to help the immune system target and destroy cancer cells by attaching to a protein called CD20 found on certain white blood cells and cancer cells. Researchers hope that mosunetuzumab might help patients live longer without their cancer progressing compared to rituximab.

Description

The main goal of this study is to see if mosunetuzumab can help patients with NLPHL live longer without their cancer getting worse compared to rituximab. Researchers will also look at the safety of both treatments and how well they work against the cancer.

Patients will be randomly assigned to one of two groups:

  • Group 1: Patients will receive mosunetuzumab injections under the skin on specific days of each treatment cycle. Treatment cycles repeat every 21 days for up to 8 cycles unless the cancer progresses or side effects become too severe. If the cancer progresses, patients may switch to the other group at week 12. Patients will also have scans and tests to monitor their cancer and overall health.

  • Group 2: Patients will receive rituximab through an IV on specific days of each treatment cycle. Treatment cycles repeat every 28 days for up to 2 cycles unless the cancer progresses or side effects become too severe. If the cancer progresses, patients may switch to the other group at week 12. Patients will also have scans and tests to monitor their cancer and overall health.

After finishing the study treatment, patients will have follow-up visits every 6 months for 2 years to check on their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL).
  • Either newly diagnosed or previously treated NLPHL.
  • Need treatment due to symptoms like fever, weight loss, or night sweats, or based on doctor’s advice.
  • Have measurable cancer according to specific medical criteria.
  • Age 18 or older.
  • Good overall health with a performance status score of 2 or less.
  • Meet specific blood count and organ function requirements.
  • HIV-positive patients must have an undetectable viral load on treatment.
  • Hepatitis B or C patients must have controlled or treated infections.
  • Agree to use effective birth control during and after the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have classical Hodgkin lymphoma or transformed NLPHL.
  • Previously treated with rituximab.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Currently receiving other experimental treatments.
  • Have cancer that has spread to the brain or spinal cord.
  • Have allergies to similar drugs.
  • Have uncontrolled health conditions that make participation unsafe.
  • Pregnant or breastfeeding women.
  • Have had a stem cell or organ transplant.
  • Have received a live vaccine recently or need one during the study.
  • Have other serious health conditions that could interfere with the study.

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