Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003179
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-07-10
Brief Title:
Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Anti Cluster of Differentiation Antigen 19 Anti-CD19 Chimeric Antigen Receptor T CAR T Cell Therapy With KymriahtIsagenlecleucel LOKI
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOKI
Brief 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
Detailed Description:
Patients will be enrolled in two stages the dose escalation stage to assess the safety and tolerability of a modified LD regimen and once the maximum tolerated dose MTD is determined a cohort expansion phase to further characterize the toxicity and efficacy profile and determine the recommended phase 2 dose RP2D The study will enroll approximately 20-40 patients in the dose escalation stage Part 1 and approximately 20 further patients at cohort expansion Part 2 There will be six dose escalation cohorts in three study arms There are two dosing cohorts in each study arm Patients in Arm 1 will receive the JULIET chemotherapy LD regimen with or without TLI and in Arms 2 and 3 intermediate doses of Cy with a fixed dose of Flu with or without TLI will be given
The cohorts in Arm 1 will enroll concurrently and enrollment into Arm 2 will begin after Arm 1 has enrolled all patients and data review by the Trial Steering Committee TSC Similarly enrollment into Arm 3 will only commence once Arm 2 has accrued and relevant safety data has been reviewed
For accrual into Cohort 2 Arm 1 there will be a 15-day staggered enrollment for the first 2 patients Staggered enrollment with another 15-day delay may be considered for enrollment into relevant cohorts in Arms 2 and 3 after review by the TSC
Following completion of accrual to Arm 1 a 30 day dose limiting toxicity DLT window will be observed prior to review by the TSC and commencement of patient enrollment into Arm 2 The same procedure and DLT window will be followed prior to patient enrollment into Arm 3
One DLT window will be observed during this study 30 days post infusion of tisagenlecleucel
The cohorts in Arm 1 will enroll concurrently and enrollment into Arm 2 will begin after Arm 1 has enrolled all patients and data review by the Trial Steering Committee TSC Similarly enrollment into Arm 3 will only commence once Arm 2 has accrued and relevant safety data has been reviewed
For accrual into Cohort 2 Arm 1 there will be a 15-day staggered enrollment for the first 2 patients Staggered enrollment with another 15-day delay may be considered for enrollment into relevant cohorts in Arms 2 and 3 after review by the TSC
Following completion of accrual to Arm 1 a 30 day dose limiting toxicity DLT window will be observed prior to review by the TSC and commencement of patient enrollment into Arm 2 The same procedure and DLT window will be followed prior to patient enrollment into Arm 3
One DLT window will be observed during this study 30 days post infusion of tisagenlecleucel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None