This phase 2 trial is evaluating the safety and effectiveness of a new targeted therapy for relapsed or unresponsive mantle cell lymphoma (MCL). The main outcome to be measured is the overall response rate to treatment.
The details
Ibrutinib (Imbruvica) is a commonly used therapy for patients with relapsed or refractory MCL. This targeted therapy blocks the growth of cancer cells but does not affect healthy cells. As a result, there are fewer side effects.
INCB050465 is a new targeted therapy. This treatment targets cancer cells and blocks their growth. This study is evaluating the safety and effectiveness of this therapy for relapsed or refractory MCL. The main outcome will be measured as the percentage of patients whose cancer shrinks or completely disappears after treatment. Safety will be evaluated from the number of patients experiencing side effects.
Who are they looking for?
This study is recruiting 180 patients with relapsed or unresponsive MCL.
Patients should not have received prior treatment with targeted therapies that are PI3K inhibitors (such as idelalisib or duvelisib). Patients should not have had an allogeneic stem cell transplant (SCT) within the last 6 months. Patients should not have had an autologous SCT within the last 3 months. Patients should not have active graft-versus-host disease (donated stem cells attack the patient’s immune system).
How will it work
This study will involve two groups of patients. The first group will be patients who have previously received ibrutinib. The second group will be patients who have not previously received ibrutinib or a similar treatment. All patients will receive the study treatment.
Safety will be measured as the number of patients who experience side effects within 16 months of starting treatment. Effectiveness will be measured as the overall response rate throughout the 16-month follow-up.
