Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-Cell Lymphoma
Sponsor: SWOG Cancer Research Network + National Cancer Institute (NCI), BeiGene
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival (PFS)
Time frame: From date of randomization to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 3 years
Trial Outcome Index (TOI) score from the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) (Patient Reported Outcome [PRO] Study)
Time frame: Baseline up to 3 months after randomization
Secondary Endpoints
Hazard ratio for PFS in the germinal center B-cell (GCB) subgroup
Hazard ratio for PFS in the non-GCB subgroup
PFS
Eligibility Criteria
Inclusion Criteria: * Participants must have: * Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines * Follicular lymphoma, grade 3B * Transformed lymphoma * High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements * Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter \>= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 28 days prior to registration. All disease must be document…
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