Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse… (NCT02594163) | Clinical Trial Compass
TerminatedPhase 2
Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma
Stopped: Sponsor decision based on portfolio prioritization
United States25 participantsStarted 2015-10
Plain-language summary
This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with confirmed CD30-positive DLBCL or grade 3b follicular non-Hodgkin lymphoma (NHL).
✓. Patients must have relapsed or refractory disease following:
✓. second-line or greater salvage systemic therapy, or
✓. frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
✓. Age 18 years and older.
✓. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET).
✓. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
✓. Acceptable blood test results.
Exclusion criteria
✕. History of another invasive malignancy that has not been in remission for at least 1 year. (Exceptions are nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma, and cervical carcinoma or a squamous intraepithelial lesion on PAP smear).
✕. History of progressive multifocal leukoencephalopathy (PML).
✕. Cerebral/meningeal disease related to the underlying malignancy, unless definitively treated.
✕. Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
✕. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
✕. Females who are pregnant or breastfeeding.
✕. Known allergy to any study drug or ingredient contained in the drug formulation of any of the study drugs.
✕. Known to be positive for hepatitis B. Known to have active hepatitis C infection or on antiviral therapy for hepatitis C within the last 6 months.