Hodgkin's disease recurrent Trials in Disease

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

This clinical trial is examining new treatment combinations for patients with classical Hodgkin lymphoma that has either returned after previous treatment or did not respond to initial therapy. The study is testing whether combining a medication called ruxolitinib with either brentuximab vedotin or pembrolizumab can improve outcomes for these patients.

Main inclusion criteria:

• Patients must be 18 years or older
• Confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma
• Must have at least one measurable tumor visible on a PET-CT scan
• For the first treatment group (ruxolitinib with brentuximab): patients must have CD30-positive disease that has relapsed or not responded after stem cell transplantation, or after at least two previous treatments if transplantation is not suitable
• For the second treatment group (ruxolitinib with pembrolizumab): patients must have received both stem cell transplantation or at least two prior therapies, but cannot have previously received PD1 or PDL1 inhibitor treatments
• Ability to perform daily activities reasonably well, as measured by a performance status scale
• Life expectancy of at least 5 months
• Willing to provide tumor biopsy and blood samples for testing

Main exclusion criteria:

• Patients whose disease only partially responded to their last treatment
• Patients who showed no improvement or whose condition worsened after the most recent treatment
• Those with partial response to salvage therapy before transplantation, unless their condition worsens later

Focus and goal of the trial:

The study aims to determine how effective these drug combinations are in treating patients with difficult-to-treat Hodgkin lymphoma. Researchers are particularly interested in measuring the rate of complete response, which means the cancer completely disappears, as well as partial response, where the cancer shrinks but does not fully go away. The trial will monitor patients throughout their treatment period, carefully tracking any side effects and how they relate to the study medications. Additionally, the study will explore whether these treatments can help prepare patients for stem cell transplants and will look for biological markers that might predict how well a patient will respond to treatment. The trial is expected to continue until 2026.

Investigational drugs being tested:

The trial is testing three medications in combination. Ruxolitinib is taken orally and works by blocking certain proteins called JAK1 and JAK2 that help cancer cells grow and survive. Brentuximab vedotin is given through an intravenous infusion and is an antibody-drug conjugate that targets a specific protein called CD30 on the surface of cancer cells, delivering a toxic substance directly to them. Pembrolizumab is also given through intravenous infusion and is an immunotherapy drug that helps the immune system recognize and attack cancer cells by blocking a protein that normally prevents the immune system from doing so.