Study on PET Adapted Brentuximab Vedotin and Pembrolizumab with Doxorubicin and Dacarbazine for Classic Hodgkin Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05922904

Provider View

This clinical trial is exploring the effects of a combination of drugs, including brentuximab vedotin and pembrolizumab, with doxorubicin and dacarbazine, in patients with certain types of Hodgkin Lymphoma who have not yet received treatment.

Patient Parameters

Program Overview

The purpose of this study is to understand how well a combination of drugs—brentuximab vedotin, pembrolizumab, doxorubicin, and dacarbazine—works in treating patients with Stage II Hodgkin Lymphoma with large tumors in the chest or advanced stages (Stage III or IV) who have not been treated before. The study will also look at the safety of this treatment and how long patients respond to it.

Description

This study aims to evaluate the effectiveness and safety of a drug combination for treating classic Hodgkin Lymphoma (cHL) in patients who have not received prior treatment. The primary goal is to see how many patients achieve complete remission after the therapy. Secondary goals include assessing the safety of the treatment, the rate of complete remission at an interim stage, overall response rates, and how long the response lasts. The study will also measure how long patients live without the disease getting worse and overall survival rates.

Eligibility Criteria

Inclusion Criteria

  • Patients who have not been treated for Hodgkin Lymphoma and have Stage III, IV, or Stage II with large tumors (over 10 cm).
  • Confirmed diagnosis of classic Hodgkin Lymphoma based on specific medical criteria.
  • Must have at least one tumor that can be measured by scans and is larger than 1.5 cm.
  • Age 18 years or older.
  • Good overall health with a performance status score of 0 or 1.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for 7 months after.
  • Men must agree to use effective birth control and not donate sperm during the study and for 7 months after.
  • Must provide written informed consent to participate.
  • Meet specific blood test requirements, including adequate blood cell counts and organ function.

Exclusion Criteria

  • Have a different type of Hodgkin Lymphoma called nodular lymphocyte predominant HL.
  • Have had another cancer within the last 3 years, except for certain types that are not likely to spread or cause death.
  • Have received certain cancer treatments or immunotherapies recently.
  • Have active brain or spinal cord disease related to cancer.
  • Have a serious infection or other medical condition that could interfere with the study.
  • Have a history of severe heart or lung disease.
  • Have received a live vaccine recently.
  • Have an active autoimmune disease requiring treatment.
  • Are pregnant or breastfeeding.
  • Have a known allergy to any of the study drugs.
  • Have a history of hepatitis B, active hepatitis C, or HIV.
  • Have received an organ or stem cell transplant.

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