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

Conditions

• Grade 3b Follicular Lymphoma
• High Grade B-Cell Lymphoma
• High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
• Recurrent Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Transformed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo optional collection of blood
• Computed Tomography — PROCEDURE
  Undergo PET/CT and CT
• Lenalidomide — DRUG
  Given PO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Tafasitamab — BIOLOGICAL
  Given IV
• Tazemetostat — DRUG
  Given PO
• Zanubrutinib — DRUG
  Given PO

Study Details

This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.

Key Dates

Start date

Sep 26, 2023

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Jan 31, 2029

Study Design

Enrollment

227 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part I, Arm I (tafasitamab, lenalidomide, tazemetostat)
  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.
• Experimental: Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib)
  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.
• Experimental: Part II, Arm I (tafasitamab, lenalidomide, tazemetostat)
  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.
• Active Comparator: Part II, Arm II (tafasitamab, lenalidomide)
  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.
• Experimental: Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib)
  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.

Primary Outcome Measure

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 ]

Central Contacts

• Katarina Gasic
  210-677-8808
  [email protected]
• Crystal Miwa
  210-677-8808
  [email protected]

Locations (104)

Find similar trials in Tucson, AZ

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