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Study of Ruxolitinib with Brentuximab or Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called classical Hodgkin lymphoma (cHL), which is a cancer of the lymphatic system. The study is specifically for patients whose cHL has returned or did not respond to previous treatments. The trial is testing the effectiveness of combining a medication called ruxolitinib with either brentuximab vedotin or pembrolizumab. Ruxolitinib is a drug that helps to block certain proteins that can cause cancer cells to grow. Brentuximab vedotin is a type of medication known as an antibody-drug conjugate, which targets cancer cells, and pembrolizumab is an immunotherapy drug that helps the immune system fight cancer.

The purpose of the study is to see how well these drug combinations work in treating patients with relapsed or refractory cHL. The study is divided into two groups, or cohorts. In one group, patients will receive ruxolitinib with brentuximab vedotin, and in the other group, patients will receive ruxolitinib with pembrolizumab. The study will monitor the patients' response to these treatments over a period of time, looking for signs of complete response, which means the cancer has disappeared, or partial response, where the cancer has shrunk but not completely gone away.

Throughout the study, researchers will also keep track of any side effects that occur and how they relate to the study drugs. The study aims to improve the rate of complete response compared to past treatments. Additionally, the study will explore the possibility of using these treatments to prepare patients for stem cell transplants, which can be a part of cancer treatment. The trial will also look for potential markers in the body that might predict how well a patient will respond to the treatment. The study is expected to continue until 2026.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria. This includes having relapsed or refractory classical Hodgkin lymphoma (cHL) and meeting other health and treatment history requirements.

    Informed consent is signed before any study-related procedures begin.

  2. Step 2

    Initial assessment

    A comprehensive health assessment is conducted. This includes a review of medical history, a physical examination, and necessary laboratory tests.

    A baseline whole-blood sample of 40 ml is collected for analysis.

  3. Step 3

    Treatment assignment

    Participants are assigned to one of two treatment groups, known as cohorts, based on their medical history and specific criteria.

    Cohort-1 receives a combination of ruxolitinib and brentuximab vedotin. Cohort-2 receives a combination of ruxolitinib and pembrolizumab.

  4. Step 4

    Treatment administration

    For Cohort-1, ruxolitinib is administered orally, and brentuximab vedotin is given through an intravenous infusion.

    For Cohort-2, ruxolitinib is administered orally, and pembrolizumab is given through an intravenous infusion.

    The treatment continues as per the study protocol, with regular monitoring and assessments.

  5. Step 5

    Interim evaluation

    An interim evaluation is conducted to assess the response to the treatment. This includes imaging studies and laboratory tests to measure the disease status.

    The primary goal is to determine the rate of complete response (CR) during or at the end of ruxolitinib treatment.

  6. Step 6

    Continuation or adjustment

    Based on the interim evaluation, the treatment may continue as planned, or adjustments may be made if necessary.

    Participants are monitored for any adverse events and their relationship to the study drugs.

  7. Step 7

    Final evaluation

    A final evaluation is conducted at the end of the treatment period to assess the overall response to the study drugs.

    This includes determining the rates of complete response, partial response, and stable disease.

  8. Step 8

    Follow-up

    Participants enter a follow-up phase where their health and disease status are monitored over time.

    The follow-up includes assessments of survival rates and any subsequent treatments received.

Who can join the trial?

18 criteria

  • Patients must have **relapsed or refractory classical Hodgkin lymphoma (cHL)**, which means the disease has returned or did not respond to previous treatments.
  • Patients must be **18 years or older**.
  • For **Cohort-1** (ruxolitinib + brentuximab):
    • Patients must have **CD30+ cHL** that has relapsed or is refractory after an **autologous stem cell transplantation (ASCT)**, or after at least two previous treatments if ASCT or other chemotherapy options are not suitable.
    • Patients cannot have received an **allotransplant** (a transplant from a donor) previously.
    • Patients must be able to receive at least 8 infusions of brentuximab.
    • Patients who progressed on brentuximab before registering with the AIFA registry can be enrolled.
    • Patients from **Cohort-2** who had important side effects from pembrolizumab and did not respond to treatment may be considered for Cohort-1.
    • For **Cohort-2** (ruxolitinib + pembrolizumab):
      • Patients must have relapsed or refractory cHL previously treated with both ASCT or at least two prior therapies when ASCT is not an option.
      • Patients can have received an allotransplant, but not a **PD1 or PDL1 inhibitor** (types of cancer treatments).
      • Patients from **Cohort-1** who had important side effects from brentuximab and did not respond to treatment may be considered for Cohort-2.
      • Patients must have a **confirmed diagnosis** of classical Hodgkin lymphoma through specific tests.
      • Patients must have at least one **measurable tumor** on a PET-CT scan.
      • Patients must provide a **tumor biopsy** sample for testing.
      • Patients must provide a **blood sample** for testing.
      • Patients must have an **ECOG performance status** of 0-1 for Cohort-1 or 0-2 for Cohort-2. This is a scale that measures how well patients can perform daily activities.
      • Patients must have a **life expectancy** of at least 5 months.
      • Any previous cancer treatment must have been completed at least 4 weeks before starting the study medication, unless the disease has clearly progressed earlier.
      • Patients must **sign an informed consent** form before any study-related procedures.

Who cannot join the trial?

3 criteria

  • Patients who have a type of cancer called cHL (classical Hodgkin Lymphoma) that has come back or not responded to treatment cannot join if they only had a partial response to their last treatment.
  • Patients who have not shown any improvement or whose condition has worsened after their last treatment are not eligible.
  • Patients who have had a partial response to their last treatment, including special treatments like salvage therapy (a treatment given after the cancer has not responded to other treatments) before a transplant (a procedure to replace damaged cells with healthy ones), cannot join unless their condition worsens later.
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Investigated drugs

  • Ruxolitinib

    is a medication used in this trial to help treat patients with relapsed or refractory classical Hodgkin lymphoma. It works by inhibiting certain proteins (JAK1/2) that are involved in the growth and survival of cancer cells. The goal is to see if it can help reduce the cancer when used in combination with other treatments.

  • Brentuximab

    is an antibody-drug conjugate used in this trial to target and destroy cancer cells in patients with classical Hodgkin lymphoma. It binds to a specific protein on the surface of the cancer cells and delivers a toxic substance directly to them, which can help to kill the cancer cells.

  • Pembrolizumab

    is an immunotherapy drug used in this trial to help the body's immune system fight cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells, thereby allowing the immune system to better recognize and destroy these cells.

What is already known about the treatment

  • Ruxolitinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory classical Hodgkin lymphoma (cHL). It is primarily used in combination with other drugs like brentuximab or pembrolizumab to enhance treatment outcomes. Ruxolitinib works by inhibiting the JAK1 and JAK2 enzymes, which play a role in the signaling pathways that promote cancer cell growth. It is classified as a JAK inhibitor and is being evaluated for its ability to achieve complete response in patients who have not responded to previous treatments.

  • Brentuximab

    Administered intravenously, brentuximab is being tested in combination with ruxolitinib for treating relapsed or refractory classical Hodgkin lymphoma (cHL). It is an antibody-drug conjugate that targets CD30, a protein found on the surface of cancer cells, delivering a cytotoxic agent directly to the cancer cells to inhibit their growth. Brentuximab is classified as an antineoplastic agent and is used to improve treatment response rates in patients who have not responded to other therapies.

  • Pembrolizumab

    This medication is given through intravenous infusion and is being studied in combination with ruxolitinib for relapsed or refractory classical Hodgkin lymphoma (cHL). Pembrolizumab is an immune checkpoint inhibitor that blocks the PD-1 pathway, enhancing the immune system's ability to detect and destroy cancer cells. It is classified as an immunotherapy drug and is being evaluated for its potential to increase complete response rates in patients with challenging cases of cHL.

Investigated diseases

Classical Hodgkin Lymphoma (cHL) – This is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It is characterized by the presence of large, abnormal cells known as Reed-Sternberg cells. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Patients with relapsed or refractory cHL have a form of the disease that has not responded to initial treatments or has returned after treatment. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of cHL can vary, with some cases advancing slowly while others may progress more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520123-83-01Protocol codecHL-PG01Estimated enrolment48 patientsSponsorUniversita' Degli Studi Di Perugia

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