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Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah

NCT06003179 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-11-12

No results posted yet for this study

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 lymphodepletion (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 chimeric antigen receptor T (CAR T) cell therapy.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

Cyclophosphamide

Conditioning chemo at different doses

RADIATION

TLI

radiation given with conditioning chemo

DRUG

Fludarabine

Fludarabine given as part of standard treatment

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • John G Kuruvilla · Princess Margaret Cancer Centre - University Health Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2026-11-30
Completion
2028-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003179 on ClinicalTrials.gov