Study on ctDNA-Guided Therapy for Relapsed or Hard-to-Treat Hodgkin Lymphoma

Sponsor: Michael Spinner, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07021989

Provider View

This clinical trial is exploring a new treatment approach for patients with Hodgkin Lymphoma that has returned or is not responding to treatment. The study uses a blood test to guide therapy and assess how well the treatment is working.

Patient Parameters

Program Overview

This study is testing a new treatment for patients with Hodgkin Lymphoma that has come back or is difficult to treat. The treatment includes a combination of drugs: pembrolizumab, gemcitabine, vinorelbine, and liposomal doxorubicin. Researchers will use a special blood test to check for tiny amounts of cancer DNA in the blood, which helps determine how well the treatment is working. The goal is to see if this approach can help patients achieve a complete response, meaning no signs of cancer, and to monitor their progress over time.

Description

The main goal of this study is to find out if the combination of pembrolizumab and other chemotherapy drugs can help patients with relapsed or hard-to-treat Hodgkin Lymphoma achieve a complete response, where no cancer is detected. Researchers will use a blood test to look for cancer DNA and see how well the treatment is working.

Secondary goals include checking how long patients live without the cancer getting worse and overall survival rates over two years. The study will also look at how many patients eventually need a stem cell transplant and compare different ways of measuring treatment response.

Participants will receive the treatment and be monitored for side effects and quality of life. The study will follow patients for up to five years to gather long-term data on the treatment's effectiveness and safety.

Participants who respond well to the initial treatment may receive additional therapy without a transplant, while those who do not respond may receive standard care and possibly a stem cell transplant. The study aims to provide insights into the best ways to treat this type of lymphoma and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of classic Hodgkin Lymphoma.
  • The disease must have returned or not responded after one previous treatment that included doxorubicin.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with a performance status score of 0, 1, or 2.
  • Have adequate organ function based on specific blood tests.
  • If you have hepatitis B or C, the infection must be under control.
  • If you have HIV, it must be well-managed with treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Must be able to understand and agree to the study requirements.

Exclusion Criteria

  • Previously received a similar treatment and the cancer progressed within 6 months.
  • Received other cancer treatments or participated in another study recently.
  • Have had a stem cell transplant before.
  • Have an autoimmune disease requiring ongoing treatment, except for thyroid disease.
  • Have a heart condition with reduced heart function.
  • Have allergies to the study drugs.
  • Have any serious medical conditions that could affect safety.
  • Are pregnant or breastfeeding.
  • Have ongoing severe side effects from previous treatments.
  • Have a blood sample that does not meet quality standards for the study.

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