Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment
NCT07275216 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2026-04-23
Summary
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
- Classic Hodgkin Lymphoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood samples
- DRUG
-
Brentuximab Vedotin
Given IV
- PROCEDURE
-
Computed Tomography
Undergo PET/CT
- DRUG
-
Dacarbazine
Given IV
- PROCEDURE
-
Echocardiography Test
Undergo ECHO
- DRUG
-
Given IV
- BIOLOGICAL
-
Given IV
- OTHER
-
Physical Performance Testing
Ancillary studies
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
- PROCEDURE
-
Pulmonary Function Test
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Matthew Mei · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2029-10-20
- Completion
- 2029-10-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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