RecruitingPhase 2NCT05821088

Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma

A Phase II Trial of Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma


Sponsor

David Bond, MD

Enrollment

37 participants

Start Date

Jun 29, 2023

Study Type

INTERVENTIONAL

Conditions

Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent Grade 3b Follicular LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell LymphomaRefractory Grade 3b Follicular LymphomaRefractory Primary Mediastinal (Thymic) Large B-Cell LymphomaRecurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell LymphomaRefractory Transformed Follicular Lymphoma to Diffuse Large B-Cell LymphomaRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRecurrent Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRefractory Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRefractory High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin LymphomaRecurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg TypeRecurrent T-Cell/Histiocyte-Rich Large B-Cell LymphomaRecurrent Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell LymphomaRefractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin LymphomaRefractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg TypeRefractory T-Cell/Histiocyte-Rich Large B-Cell LymphomaRefractory Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Summary

This phase II clinical trial evaluates tafasitamab and lenalidomide followed by tafasitamab and the carboplatin, etoposide and ifosfamide (ICE) regimen as salvage therapy for transplant eligible patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide may have antineoplastic activity which may help block the formation of growths that may become cancer. Drugs used in chemotherapy, such as carboplatin, etoposide and ifosfamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tafasitamab and lenalidomide followed by ICE may be a better treatment for patients with relapsed or refractory large B-cell lymphomas.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment sequence for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — a fast-growing blood cancer that has come back or stopped responding to treatment. The approach uses tafasitamab (an antibody drug) with lenalidomide (an immune-modulating drug) followed by intensive chemotherapy and potentially a stem cell transplant, aiming to put the cancer into deep remission before transplant. **You may be eligible if...** - You are 18 or older - You have DLBCL that has relapsed or not responded to at least one prior treatment including an anti-CD20 antibody (such as rituximab) and chemotherapy - You are considered eligible for a stem cell transplant by your doctor - You have measurable disease on a CT or PET scan - Your overall health is acceptable (ECOG 0–2) **You may NOT be eligible if...** - You have received more than one prior line of therapy - You have active central nervous system lymphoma - You are pregnant or breastfeeding - You have serious heart, liver, or kidney conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCarboplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT

DRUGEtoposide

Given IV

DRUGIfosfamide

Given IV

DRUGLenalidomide

Given PO

PROCEDUREPositron Emission Tomography

Undergo PET

BIOLOGICALTafasitamab

Given IV


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05821088


Related Trials