Actively Recruiting
Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment
Led by City of Hope Medical Center · Updated on 2026-04-23
23
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.
CONDITIONS
Official Title
Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent and assent if applicable
- Allow use of diagnostic tumor biopsy tissue or get approval for exception
- Unsuitable for standard anthracycline chemotherapy due to age 75 or older, ECOG 2-4, low heart function, impaired kidney clearance, or poor lung function
- ECOG performance status of 2 or less
- Age 18 years or older
- Newly diagnosed with classical Hodgkin lymphoma (excluding nodular lymphocyte predominant subtype) confirmed by pathology
- No prior systemic treatment for Hodgkin lymphoma except limited corticosteroids stopped before treatment start
- Have measurable disease with at least one lesion 1.5 cm or larger
- Absolute neutrophil count of 1000/mm3 or higher without recent growth factor use
- Platelet count of 50,000/mm3 or higher without recent transfusions
- Total bilirubin 2 times or less upper limit of normal or direct bilirubin 2 times or less for Gilbert's disease
- AST and ALT liver enzymes 3 times or less upper limit of normal, or 5 times or less if liver involved
- For P-BV-D therapy patients, kidney function clearance 30 mL/min or higher
- Normal blood clotting tests (INR and aPTT) or within therapeutic range if on anticoagulants
- Negative for hepatitis C and hepatitis B surface antigen; if positive, undetectable viral load and willing to monitor
- Women of childbearing potential must have a negative pregnancy test and follow contraception guidance
- Male participants must agree to use contraception during and for 6 months after treatment
- Eligible females are not pregnant or breastfeeding and follow contraception if applicable
- For salvage therapy, must meet specific health and blood count criteria and have peripheral neuropathy grade 2 or less
You will not qualify if you...
- Receiving other investigational treatments
- Received live vaccines within 30 days before starting treatment
- Peripheral neuropathy grade 2 or higher
- Need for dialysis or very low kidney function for P-BV-D therapy
- Active lymphoma involvement in the central nervous system
- Severe allergic reactions to brentuximab vedotin or pembrolizumab
- Uncontrolled infections despite treatment
- Recent other cancers within 3 years except some skin or cervical cancers or cancers not needing treatment
- Current use of high-dose systemic steroids or immunosuppressive drugs except some exceptions
- History of progressive multifocal leukoencephalopathy
- Active lung inflammation or disease
- Prior solid organ or stem cell transplant
- History or suspicion of hemophagocytic lymphohistiocytosis
- Active autoimmune diseases except specific controlled conditions
- Active hepatitis B or C infection unless controlled and monitored
- HIV positive
- Recent serious heart or vascular events within 6 months
- Any condition that makes participation unsafe or compliance unlikely as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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