DLBCL Non Hodgkin Lymphoma
Conditions
Interventions
NVT
Sponsors
Seagen Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non- GCB) will be histologically determined by the most recent local pathology assessment for the purposes of study eligibility and stratification. - Participants must have R/R disease following 2 or more lines of prior systemic therapy. For subjects with transformed DLBCL (subtype k), at least the last systemic therapy used must have been for DLBCL. - Participants must be HSCT or CAR-T ineligible according to the investigator and must meet at least one of the following criteria: o One or more co-morbidities, including cardiac, pulmonary, renal or hepatic dysfunction that in the opinion of the Investigator make the subject medically unfit to received HSCT or CAR-T therapy o Active disease following induction and salvage chemotherapy o Inadequate stem cell mobilization (for HSCT) o Relapse following prior HSCT or CAR-T o Unable to receive CAR-T therapy due to financial, geographic, insurance or manufacturing issues - Participants must have tumor tissue submitted to the central pathology lab for the determination of CD30 expression. - An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 - Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and bidimensional measurable disease of >1.5 cm by computed tomography (CT), as assessed by the site radiologist within 28 days of Day 1. Other protocol defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: - History of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. - History of progressive multifocal leukoencephalopathy (PML). - Active cerebral/meningeal disease related to the underlying malignancy. Subjects with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months. - Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted - Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment - Participants who are breastfeeding - Known hypersensitivity to any study drug or excipient contained in the drug formulation of the study drugs - Any contraindication to associated study treatments. - Known to be positive for hepatitis B by surface antigen expression. - Subjects who are hepatitis B surface antigen (HBsAg) negative but hepatitis B core antibody (HBcAb) positive are eligible, but should start hepatitis B prophylaxis therapy prior to receiving the first dose of rituximab. Known to be positive for hepatitis C (HCV) infection (either confirmed positive by polymerase chain reaction [PCR] or on antiviral therapy for hepatitis C within the last 6 months). Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks. - Participants with previous allogeneic HSCT if they meet either of the following criteria: 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate and compare PFS between the 2 treatment arms in the intent-to-treat (ITT) population Evaluate and compare PFS between the 2 treatment arms in the CD30-positive population | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate and compare OS between the 2 treatment arms in the ITT population * Evaluate and compare OS between the 2 treatment arms CD30-positive population * OS in the ITT population * OS in the CD30-positive population * Evaluate and compare objective response rate (ORR) between the 2 treatment arms in the ITT population | — |
Countries
Netherlands
Outcome results
None listed