Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07275216
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Classic Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Brentuximab Vedotin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Dacarbazine — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Gemcitabine — DRUG
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Physical Performance Testing — OTHER
    Ancillary studies
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Pulmonary Function Test — PROCEDURE
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Oct 20, 2029
Completion
Oct 20, 2029

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (P-G, P-BV-D)
    See Detailed Description.

Primary Outcome Measure

Complete metabolic response (CMR) to pembrolizumab and gemcitabine (P-G) [ Time Frame: During/after cycles 1-8 of P-G (cycle length = 21 days), before initiation of salvage or maintenance therapy or non-protocol lymphoma therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Matthew Mei
[email protected]
626-218-2405
Matthew Mei (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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