Actively Recruiting
PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy
Led by M.D. Anderson Cancer Center · Updated on 2026-02-19
31
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies the effect of brentuximab vedotin and nivolumab alone and in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone in treating patients with untreated, stage I-IV primary mediastinal large B-cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent, called vedotin. Brentuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD30 receptors, and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab is a type of antibody therapy, which targets and attaches to the CD20 protein found on the surface of blood cells with cancer and some healthy blood cells. Chemotherapy drugs, such as cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, or by stopping them from dividing. Prednisone is a steroid, a hormone (chemical messengers) with multiple roles, notably in the immune system and inflammation reduction. Steroids are poisonous to lymphocytes (white blood cells from which lymphomas develop). Giving brentuximab vedotin and nivolumab in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone may help to control the disease and be a less harmful regimen than standard chemotherapy in patients with primary mediastinal large B-cell lymphoma.
CONDITIONS
Official Title
PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed diagnosis of primary mediastinal large B-cell lymphoma
- CD30 expression level of 1% or greater in tumor or tumor-infiltrating lymphocytes
- No prior treatment except limited-field radiotherapy or short course (up to 7 days) of glucocorticoids <=100 mg prednisone equivalent
- Stage II, III, IV or stage I with tumor size >= 5 cm
- Age 18 years or older at consent
- Bi-dimensional measurable disease with longest dimension >= 1.5 cm
- Performance status of 3 or less (3 allowed if related to lymphoma and potentially reversible)
- Serum bilirubin less than 1.5 times upper limit of normal (ULN) except Gilbert's syndrome
- AST and ALT less than or equal to 3 times ULN or less than 5 times ULN if hepatic metastases present
- Absolute neutrophil count greater than 1000/mm3 unless related to lymphoma and potentially reversible
- Platelets greater than 1000/mm3 unless related to lymphoma and potentially reversible
- Creatinine clearance equal to or greater than 30 ml/min
- Willingness to receive blood transfusions
- Negative pregnancy test for women of childbearing potential
- Use of highly effective birth control during and after study (12 months for women, 3 months for men)
You will not qualify if you...
- Urgent need for cytoreductive treatment
- Serious uncontrolled medical conditions including uncontrolled hypertension, congestive heart failure (class 3 or 4), diabetes, active coronary artery disease, COPD, renal failure, active infection, invasive fungal infection, moderate to severe liver disease, active bleeding, psychiatric illness preventing consent
- Prior anthracycline exposure exceeding lifetime doxorubicin dose of 450 mg/m2
- Pregnant or lactating females
- Known hypersensitivity to study drugs brentuximab vedotin, nivolumab, rituximab, doxorubicin, cyclophosphamide, or prednisone
- Active HIV infection with viremia (except controlled HIV with undetectable viral load and CD4 >= 300 on HAART)
- Active hepatitis B or C viremia (except prior vaccination or cleared infection)
- Central nervous system lymphoma involvement
- Prior malignancy within 2 years except certain treated skin or cervical cancers and prostate cancer in remission
- Significant neuropathy (grade 2 or grade 1 with pain) within 14 days prior to enrollment
- Contraindication or intolerance to required drugs or hydration
- Major surgery within 4 weeks or unhealed wounds
- Stroke or brain hemorrhage within 6 months
- Vaccination with live attenuated vaccines within 4 weeks before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Ranjit Nair
CONTACT
R
Ranjit Nair
CONTACT
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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