Fitness-Adapted Pembrolizumab-Based Therapy for Untreated Classical Hodgkin Lymphoma in Patients Aged 60 and Above

Sponsor: University of Virginia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05404945

This study is testing a new treatment plan for older adults with classical Hodgkin lymphoma who have not received treatment before. The plan includes the drug pembrolizumab, with adjustments based on the patient's fitness level, to see if it effectively treats the cancer.

Patient Parameters

Program Overview

This clinical trial is exploring a new treatment approach for older patients with classical Hodgkin lymphoma who have not been treated before. The study involves using pembrolizumab, a medication given every six weeks, along with other drugs. Patients will be assessed for their fitness level to determine the best treatment plan. Those considered 'frail' will receive pembrolizumab with brentuximab vedotin, while 'fit' patients will receive pembrolizumab with a combination of chemotherapy drugs. The goal is to find out if this tailored approach can effectively treat the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 60 years or older.
  • Willing and able to provide written consent and participate in all study procedures.
  • Diagnosed with classical Hodgkin lymphoma.
  • Have a measurable tumor that can be seen on a PET scan.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • May have had radiation treatment before, but with certain conditions.
  • Have adequate organ function based on specific medical tests.

Exclusion Criteria

  • Have a different type of Hodgkin lymphoma.
  • Life expectancy of less than 6 months for reasons other than lymphoma.
  • Have received certain immune therapies before, unless under specific conditions.
  • Have had previous systemic therapy for Hodgkin lymphoma, except for steroids.
  • Have significant nerve damage or have had a transplant.
  • Have cancer affecting the brain or spinal cord.
  • Have received a live vaccine recently.
  • Are participating in another clinical trial with an investigational drug.
  • Have an immune deficiency or are on high-dose steroids.
  • Have another active cancer or severe allergies to pembrolizumab.
  • Have an active autoimmune disease or lung disease requiring steroids.
  • Have a history of pancreatitis or active infections.
  • Have a history of HIV, Hepatitis B, or active Hepatitis C.
  • Have active tuberculosis.
  • Are taking certain medications that affect the liver.
  • Have any condition that might interfere with the study.
  • Have psychiatric or substance abuse issues that affect participation.
  • Are pregnant, breastfeeding, or planning to have children during the study.

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