Personalized Chemotherapy Reduction Using ctDNA for Advanced Hodgkin Lymphoma Treatment

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06745076

Provider View

This study is exploring a personalized approach to chemotherapy for patients with advanced Hodgkin Lymphoma. By measuring tumor DNA in the blood, doctors can adjust the intensity of chemotherapy to better suit each patient's needs.

Patient Parameters

Program Overview

This phase II study is testing a personalized approach to chemotherapy for patients with advanced Hodgkin Lymphoma, a type of cancer that may have spread to nearby tissues or distant parts of the body. The study uses a method called ctDNA evaluation, which measures tumor DNA in the blood, to decide whether patients can receive a reduced amount of chemotherapy. The chemotherapy drugs used in this study include nivolumab, doxorubicin, vinblastine, and dacarbazine. These drugs work by killing cancer cells or stopping them from growing and spreading. By using ctDNA to guide treatment, the study aims to provide effective care while potentially reducing the side effects of chemotherapy.

Description

Study Outline:

Cycles 1-2: All patients receive chemotherapy drugs (nivolumab, doxorubicin, vinblastine, and dacarbazine) through an IV on days 1 and 15 of each cycle. Each cycle lasts 28 days, and patients undergo two cycles unless the disease progresses or side effects become too severe. After these cycles, patients are tested for measurable residual disease (MRD).

  • Arm I (MRD Negative):

    • Cycles 3-4: Continue receiving the same chemotherapy drugs on days 1 and 15 of each cycle for two more cycles.
    • Cycles 5-6: Receive only nivolumab on days 1 and 15 of each cycle for two cycles.

  • Arm II (MRD Positive):

    • Cycles 3-6: Continue receiving all four chemotherapy drugs on days 1 and 15 of each cycle for four more cycles.

After completing the treatment, patients are monitored every three months for a year and then periodically for up to five years. Throughout the study, patients will have heart scans, PET-CT scans, complete questionnaires, and provide blood samples.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with classical Hodgkin lymphoma, stage 3 or 4, without prior systemic therapy.
  • Have measurable disease according to specific medical criteria.
  • Suitable for six cycles of combination chemotherapy.
  • No active lymphoma in the central nervous system.
  • ECOG performance status of 0-2, indicating good overall health.
  • Meet specific blood count and organ function requirements.
  • Aged 18 or older.
  • Must understand the study and provide written consent.
  • Must be able to complete all planned study treatments.
  • Men must use barrier contraception during and after treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and use two methods of birth control during and after the study.

Exclusion Criteria

  • Positive for HIV or hepatitis B/C with detectable viral load, unless on treatment with undetectable levels.
  • Pregnant or nursing women, or those not using effective contraception.
  • Other cancers, unless treated and disease-free for at least two years.
  • Medical conditions that prevent aggressive chemotherapy, such as severe heart or lung disease.
  • Active heart disease or heart failure.
  • Use of other cancer treatments or experimental drugs.
  • Autoimmune diseases, except for stable thyroid disease or vitiligo.
  • History of lung disease requiring steroids.
  • Use of supplemental oxygen.
  • Recent live vaccines within 30 days before starting treatment.

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