Study on Pembrolizumab and Chemotherapy for Untreated B Cell Lymphoma
Sponsor: University of Chicago
Sponsor score: 0
Inactive
ClinicalTrials ID:NCT03995147
This clinical trial is exploring how well the drug pembrolizumab works when combined with a chemotherapy regimen called R-CHOP in patients with untreated non-germinal center diffuse large B cell lymphoma.
Patient Parameters
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Program Overview
The purpose of this study is to understand how patients with untreated non-germinal center diffuse large B cell lymphoma respond to a combination of pembrolizumab and a chemotherapy regimen known as R-CHOP, which includes the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with a confirmed diagnosis of diffuse large B cell lymphoma or high-grade B cell lymphoma of a specific type.
- Have a high-risk score based on the International Prognostic Index (IPI).
- Men must agree to use contraception during treatment and for 120 days after the last dose.
- Women must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
- Must provide written consent to participate.
- Have at least one measurable tumor.
- Able to provide a tumor sample for analysis.
- Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Have adequate organ function based on specific blood test results.
Exclusion Criteria
- Positive pregnancy test before starting treatment.
- Previous treatment with certain immune therapies or any anti-lymphoma therapy.
- Recent receipt of a live vaccine.
- Participation in another clinical trial recently.
- Have an immune deficiency or are on high-dose steroids or other immune-suppressing drugs.
- Have another active cancer that required treatment in the past two years, with some exceptions.
- Have active lymphoma in the central nervous system.
- Have certain types of high-grade B cell lymphoma or untreated low-grade lymphoma that has transformed.
- Severe allergy to pembrolizumab or its ingredients.
- Have an active autoimmune disease needing treatment in the past two years.
- Have a history of lung inflammation needing steroids.
- Have an active infection needing treatment.
- Have a history of HIV, Hepatitis B, or active Hepatitis C.
- Have a history of tuberculosis.
- Have had an organ transplant.
- Have certain heart conditions or recent heart attack.
- Have any condition that might interfere with the study or is not in the best interest of the patient.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Are pregnant, breastfeeding, or planning to have children during the study and for 120 days after the last treatment.
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