This trial is examining the safety and effectiveness ofpembrolizumab (Keytruda) in the treatment of children and young adults with classical Hodgkin lymphoma (HL).
The main outcome to be measured will be a response to treatment. This trial is recruiting in the Republic of Korea and the United States.
The details
Pembrolizumab is a cancer treatment. It works by using the immune system to kill the cancer cells. It is used in many different types of cancer. There are two main types of response to initial HL treatment.
This trial is examining the safety and effectiveness of pembrolizumab in the treatment of children and young adults with classical HL who are slow early responders to initial chemotherapy. The main outcome to be measured will be a response to treatment. This will be assessed for up to 5 years.
Who are they looking for?
This study requires 440 patients with newly diagnosed classical HL. Patients must have adequate organ function. Sexually active patients must use contraception during the trial and for 120 days after the treatment period.
Patients should not have received a solid organ transplant at any time, or stem cell transplantation within the last 5 years. Patients will not qualify if they are participating in another clinical trial. Patients must not be immunocompromised, have an autoimmune disease or receive chronic steroid therapy. Patients with another progressive cancer will be excluded. Patients should not have cancer that has spread to the brain or meningitis related to the cancer, heart failure or an active infection.
How will it work
There will be two groups in this study. Group 1 (low-risk patients) will receive pembrolizumab and AVD chemotherapy (doxorubicin, vinblastine, dacarbazine, and bleomycin). Patients will also receive radiotherapy after chemotherapy if they are slow-responders.
Group 2 (high-risk patients) will receive pembrolizumab and COPDAC-28 chemotherapy (cyclophosphamide, vincristine, prednisolone, and dacarbazine). Patients in group 2 will receive radiotherapy if necessary, based on scan results.
Response to treatment and survival will be evaluated for up to 5 years.
