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Pembrolizumab-Based Therapy for Hodgkin's Lymphoma
Study Summary
This trial is testing a new fitness-adapted regimen for previously untreated older patients with classical Hodgkin lymphoma. The first cycle of treatment will be with pembrolizumab and brentuximab vedotin, followed by an assessment of fitness. Those deemed "non-fit" will continue treatment with pembrolizumab and brentuximab vedotin for 3 more cycles, then will switch to single-agent pembrolizumab for 4 additional cycles. Those deemed "fit" will switch from brentuximab vedotin to concurrently-administered combination chemotherapy using doxor
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I can care for myself but might not be fully active due to my lymphoma.I have an active tuberculosis infection.I have or had hepatitis B or C, but if B, I'm not currently infectious.I have or had lung disease that needed steroids.I am not currently on strong CYP3A4 modulators, or I can safely stop them before treatment.I am 60 years old or older.I have had treatment for Hodgkin lymphoma, but only steroids.My condition is nodular lymphocyte-predominant Hodgkin lymphoma.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 3 years.I have been diagnosed with classical Hodgkin lymphoma.My cancer shows up on PET scans and is at least 1.5cm big.I have a history of pancreatitis.I am currently on medication for an active infection.I had immunotherapy over 3 years ago without severe side effects.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had a solid organ or stem cell transplant in the past.My lymphoma is affecting my brain, spinal cord, or the fluid around it, but not just pressing on it from the outside.My doctor expects I have more than 6 months to live, not counting my lymphoma.I have fully recovered from any major surgery before starting the study treatment.I experience significant numbness or weakness.I have not received a live vaccine within the last 30 days.I have been diagnosed with HIV.I have received radiation therapy targeted at a specific area.
Frequently Asked Questions
Has Pembrolizumab been cleared by the FDA?
"Pembrolizumab falls into the Phase 2 category, meaning that while there is some evidence supporting its safety, there is no data indicating whether or not it is effective. Our team at Power gave it a score of 2."
Are there any more slots open for willing participants in this research project?
"Yes, according to the information available on clinicaltrials.gov, this study is looking for 44 individuals to take part in the trial at a single location. The original posting was on 7/26/2022 and there was one update on 7/27/2022."
What are the goals that this medical study is hoping to achieve?
"According to the sponsor of this trial, Merck Sharp & Dohme LLC, the primary outcome being measured over a period of 2 years is Complete Remission Rate. Additionally, this study will also assess secondary outcomes including but not limited to: remission rate after lead-in therapy, progression-free survival (PFS), overall survival (OS), and lymphoma specific survival in both the fit and non-fit older population."
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