Actively Recruiting
Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma
Led by City of Hope Medical Center · Updated on 2026-04-23
23
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how well pembrolizumab combined with chemotherapy drugs gemcitabine, brentuximab vedotin, and dacarbazine works in treating frail patients with newly diagnosed classical Hodgkin lymphoma who cannot receive standard anthracycline-based treatment. This phase II trial explores the use of immunotherapy with pembrolizumab to help the immune system attack cancer cells, alongside chemotherapy agents that target and kill lymphoma cells. The study aims to find effective alternative treatments and assess their safety in this vulnerable patient group. Participants receive treatment in several phases. First, for up to 8 cycles, they get pembrolizumab and gemcitabine intravenously every 21 days. If their disease does not progress, some then receive maintenance therapy with pembrolizumab every 42 days for up to 4 cycles. If the disease progresses, patients move to salvage therapy with pembrolizumab, brentuximab vedotin, and dacarbazine every 21 days for up to 12 cycles. Throughout the study, patients will undergo scans like PET/CT and may have heart and lung function tests. During the trial, researchers monitor patients closely, collecting blood samples and assessing physical performance. They measure outcomes such as complete metabolic response, overall response, progression-free survival, duration of response, and overall survival up to 24 months. Safety is also evaluated by tracking adverse events. Follow-up visits occur at 30 days, then at 12, 18 (for salvage therapy patients), and 24 months after treatment completion to observe long-term effects and patient health.
CONDITIONS
Brief 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...
- Documented informed consent from participant or legal representative
- Agreement to allow use of archival tissue from tumor biopsies or PI approval if unavailable
- Frailty defined by age 75 or older, ECOG score 2-4, low heart ejection fraction (<50%), low kidney function (<60 mL/min), or lung impairment (FEV1 or DLCO <50%)
- ECOG performance status 2 or less
- Age 18 years or older
- New diagnosis of classical Hodgkin lymphoma confirmed by pathology
- No prior systemic treatment for Hodgkin lymphoma except limited corticosteroids
- Measurable disease with at least one lesion 1.5 cm or larger
- Adequate neutrophil count (ANC ≥ 1,000/mm3) without recent growth factors
- Adequate platelets (≥ 50,000/mm3) without recent transfusions
- Liver function tests within defined limits
- For salvage therapy, creatinine clearance ≥ 30 mL/min
- Appropriate blood clotting test results
- Negative or controlled hepatitis B or C infection
- Negative pregnancy test for women of childbearing potential
- Use of contraception during treatment and for 6 months after in males
- Women not pregnant or breastfeeding and agree to contraceptive guidance
- For salvage therapy, specific blood counts and organ function criteria including neuropathy ≤ grade 2
You will not qualify if you...
- Use of other investigational therapy
- Live vaccine within 30 days before treatment
- Peripheral neuropathy grade 2 or higher
- Need for dialysis or very low kidney function for salvage therapy
- Active central nervous system lymphoma involvement
- Severe allergy to study drugs
- Uncontrolled infections
- Recent other cancers except certain skin and cervical cancers
- Recent use of systemic steroids or immunosuppressants except allowed exceptions
- History of progressive multifocal leukoencephalopathy
- Active lung disease like pneumonitis
- Prior organ or stem cell transplant
- Known or suspected hemophagocytic lymphohistiocytosis
- Active or suspected autoimmune diseases except certain controlled conditions
- Active hepatitis B or C infection not controlled
- HIV positive
- Recent serious heart events or unstable heart symptoms
- Any other safety concerns as judged by investigator
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (8 cycles of 21 days each)
Participants receive pembrolizumab and gemcitabine every 21 days for up to 8 cycles unless disease progresses or toxicity occurs. Those without progression continue to pembrolizumab maintenance; those with progression move to salvage therapy.
Every 21 days for up to 8 cycles
Duration - Up to 16 weeks (4 cycles of 42 days each)
Participants without disease progression after initial treatment receive pembrolizumab maintenance every 42 days for up to 4 cycles unless disease progresses or toxicity occurs.
Every 42 days for up to 4 cycles
Duration - Up to 36 weeks (12 cycles of 21 days each)
Participants with disease progression after initial treatment receive salvage therapy with pembrolizumab, brentuximab vedotin, and dacarbazine every 21 days for up to 12 cycles unless progression or toxicity occurs.
Every 21 days for up to 12 cycles
Duration - Up to 24 months
After completing study treatment, participants are followed up to monitor their health and outcomes.
Visits at 30 days, and at 12, 18 (for salvage patients), and 24 months
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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