Pembrolizumab in Combination With Chemotherapy for Patients With Untreated B Cell Lymphoma (NCT03995147) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab in Combination With Chemotherapy for Patients With Untreated B Cell Lymphoma
United States51 participantsStarted 2019-08-29
Plain-language summary
This study will research untreated non-germinal center diffuse large B cell lymphoma and what causes the disease and the way patients respond to pembrolizumab combined with R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of diffuse large B cell lymphoma or high-grade B cell lymphoma of a non-germinal center phenotype according to Hans criteria are eligible for enrollment in this study.
✓. International Prognostic Index (IPI) score of ≥ 3, or an age-adjusted (aa) IPI score of ≥ 2.
✓. A male participant must agree to use a contraception during the treatment period and for at least 120 days after the final dose of study treatment and refrain from donating sperm during this period.
✓. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
✓. Not a woman of childbearing potential (WOCBP) OR
✓. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
✓. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
✓. Have measurable disease with one or more measurable lymphoma lesions ( \>1.5 cm in the long axis and \>1.0 cm in the short axis).
Exclusion criteria
✕. Positive urine pregnancy test within 72 hours prior to the initiation of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
What they're measuring
1
Progression free survival (PFS) rate when combining pembrolizumab with R-CHOP
. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
✕. Has received prior anti-lymphoma therapy, including radiation therapy, chemotherapy, targeted therapy, or immunotherapy.
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent, with the exception of short-term corticosteroid use to control lymphoma-related symptoms as outlined above) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Other exceptions may be permitted after discussion with the principal investigator.
✕. Has known active CNS involvement by lymphoma.