RecruitingPhase 1NCT05950802

Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta

Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving CAR T Cell Therapy With Yescarta/AxicabtageNeciloleucel (ODIN)


Sponsor

University Health Network, Toronto

Enrollment

40 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different methods of preparing the immune system (called lymphodepletion) before a type of advanced immune cell therapy called CAR-T (specifically axicabtagene ciloleucel, or Yescarta) in people with a type of aggressive blood cancer called large B-cell lymphoma. The goal is to improve outcomes by optimizing the pre-treatment process. **You may be eligible if...** - You are 18 or older with relapsed or refractory large B-cell lymphoma (including DLBCL) - You have received at least 2 prior lines of treatment, including anti-CD20 therapy and an anthracycline (a type of chemotherapy) - You are otherwise eligible for standard CAR-T cell therapy - Your overall health and organ function are adequate (ECOG 0-1) - You have not had prior CD19-targeted therapy or allogeneic (donor) stem cell transplant **You may NOT be eligible if...** - You are HIV positive or have active hepatitis B or C - You have active brain involvement by lymphoma - You have had a heart attack, severe heart failure, or serious cardiac disease in the past 12 months - You have a history of severe autoimmune disease requiring immunosuppression - You have an uncontrolled active infection - You are pregnant or breastfeeding 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.

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Interventions

DRUGCyclophosphamide

Higher dose than traditional conditioning chemo

RADIATIONTLI

radiation given with conditioning chemo


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT05950802


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