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NCT05890352

Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 11 months later.

See at-risk trials from SWOG Cancer Research Network

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Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Dec 1, 2029 Show 5 more changesShow less
    • Study completion pushed from Jan 2029 to Dec 2029
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Study description revised
    • Site details revised at 6 of 104 sites
  2. Study sites: 11 to 104v7
  3. Start date changed from estimate of Sep 1, 2023 to Sep 26, 2023v5
  4. Study sites: 1 to 11v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 7, 2023 to Sep 1, 2023
    • Study sites: 0 to 1
    v3
  6. Primary endpoints revised (2)
    • Study title shortened, about 10 words
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression-free survival (PFS)
Timeframe: 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)
Timeframe: Baseline up to 3 months after randomization

Secondary (10)

Hazard ratio for PFS in the germinal center B-cell (GCB) subgroup
Hazard ratio for PFS in the non-GCB subgroup
PFS
Overall response rate (ORR)
Complete response (CR) rate
Show 5 moreShow less
Partial response (PR) rate
Duration of response (DOR)
Event free survival (EFS)
Overall survival (OS)
Incidence of adverse events

Arms and interventions

Part I, Arm I (tafasitamab, lenalidomide, tazemetostat)Experimental

Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.

Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib)Experimental

Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.

Part II, Arm I (tafasitamab, lenalidomide, tazemetostat)Experimental

Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.

Part II, Arm II (tafasitamab, lenalidomide)Active comparator

Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.

Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib)Experimental

Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.

Procedures: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography

Drugs: Lenalidomide, Tazemetostat, Zanubrutinib

Other: Quality-of-Life Assessment, Questionnaire Administration

Biologicals: Tafasitamab

Sites

104 sites in 1 country