Study on Brentuximab Vedotin With or Without Nivolumab for Treating Patients with Returning or Resistant CD30+ Lymphoma

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01703949

Provider View

This clinical trial is exploring how well the drug brentuximab vedotin, with or without nivolumab, works in treating patients with CD30+ lymphoma that has returned after treatment or is not responding to current treatments. The study aims to see if these drugs can help stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This study is testing the effectiveness of brentuximab vedotin, a drug that may help the immune system fight cancer, with or without another drug called nivolumab, in patients with CD30+ lymphoma. This type of lymphoma has either come back after treatment or has not responded to previous treatments. The study will help determine if these drugs can better control the cancer.

Description

The study is divided into two groups:

  • Group A (Closed to New Participants): Patients received brentuximab vedotin through an IV infusion over 30 minutes on days 1, 8, and 15. This treatment was repeated every 28 days for up to 4 cycles, as long as the cancer did not progress or cause unacceptable side effects.

  • Group B: Patients receive brentuximab vedotin through an IV infusion over 30 minutes and nivolumab through an IV infusion over 30-60 minutes on day 1. This treatment is repeated every 21 days for up to 4 cycles, as long as the cancer does not progress or cause unacceptable side effects.

After finishing the study treatment, patients will have follow-up visits at 3-5 weeks, every 3 months for the first year, and then every 6 months for the next four years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have CD30+ lymphoma that has returned or not responded to treatment with brentuximab vedotin.
  • Cancer cells must show CD30 markers.
  • Have certain blood counts and organ function levels within specified limits.
  • Have measurable cancer by scans or other criteria.
  • Be 18 years or older.
  • Have resolved any side effects from previous treatments to a mild level.
  • Be informed about the study and agree to participate by signing a consent form.
  • Be expected to complete at least 2 cycles of chemotherapy in the study.
  • Have an expected survival of more than 90 days if untreated.

Exclusion Criteria

  • Have had a transplant within the last 100 days.
  • Have received radioimmunotherapy within the last 12 weeks.
  • Have known HIV or hepatitis B infection, or a history of a specific brain infection.
  • Have an active infection or medical condition that would prevent treatment.
  • Have a performance status score greater than 2, indicating limited ability to carry out daily activities.
  • Have active cancer in the central nervous system.
  • Have severe nerve damage from previous treatments.
  • Cannot tolerate brentuximab vedotin.
  • Are using other cancer treatments or experimental drugs.
  • Have an autoimmune disease, except for certain conditions, if in Group B.
  • Are pregnant or breastfeeding, or not using effective birth control if of childbearing potential.

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