This trial is evaluating the effects of second-line pembrolizumab (Keytruda) plus GVD (gemcitabine, vinorelbine, doxorubicin) for relapsed (recurrent cancer) or refractory (does not respond to treatment) Hodgkin’s lymphoma (HL). The main outcome to be measured is the number of patients who achieve a complete response (disappearance of all signs of cancer). This study is being conducted in New York City, NY, in the United States.
The details
Most patients with HL respond to first-line chemotherapy regimens. However, up to 20% of patients experience relapse or progression (tumor grows or spreads) after initial treatment. Patients who develop refractory disease tend to have a poor prognosis. New treatment options are needed for these patients.
This study is evaluating the effects of second-line pembrolizumab plus GVD chemotherapy in patients with relapsed or refractory HL. The main outcome studied is the percentage of patients who achieve a complete response.
Who are they looking for?
This study is recruiting 39 participants. To participate in this study, patients must be eligible for a stem cell transplant (SCT). Patients must have had only 1 prior line of multi-agent chemotherapy. Patients must agree to use contraception.
Patients who have received radiotherapy within 2 weeks of starting study treatment cannot participate. Patients who had an organ transplant at any time or allogeneic SCT within the last 5 years cannot participate. Patients should not have active infections or any autoimmune disease that requires systemic therapy. Patients who have received a live vaccine within 30 days of starting study treatment cannot participate.
How will it work
All patients will receive 2 to 4 cycles of pembrolizumab plus GVD chemotherapy. After treatment, healthy stem cells will be collected from patients. These cells may be used for a future stem cell transplant.
The complete response rate will be measured by determining how many patients achieve a complete response 2 years after treatment.
