Status:
ACTIVE_NOT_RECRUITING
RadiothErapy priMIng for CAR-T
Lead Sponsor:
University College, London
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The REMIT trial will investigate radiotherapy as a preferred bridging method prior to Tisagenlecleucel infusion in patients with relapsed or refractory Diffuse Large B Cell Lymphoma
Detailed Description
The REMIT Trial is an open label, single arm phase IIa study investigating Radiotherapy as preferred bridging method prior to Tisagenlecleucel treatment in patients with relapsed or refractory Diffuse...
Eligibility Criteria
Inclusion
- Written informed consent
- Age ≥ 18 years
- Histologically proven DLBCL, including transformed follicular or marginal zone lymphoma
- Measurable disease on cross-sectional imaging that is at least 1.5cm in the longest diameter and measurable in two perpendicular dimensions
- Relapsed/refractory after 2 or more standard immuno-chemotherapies
- Approved to receive Tisagenlecleucel as per the licenced indication
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Disease accessible for repeat biopsies (Selected patients only)
- Disease amenable to radiotherapy as assessed by the treating clinical oncologist
- Willing and able to comply with the requirements of the protocol, including contraceptive advice as per the protocol
Exclusion
- Prior radiotherapy at location/dose that would interfere with application of radiotherapy or outcome measures in this trial
- Women who are pregnant or breast feeding
- Previous therapy with any genetically modified autologous or allogeneic T-cell immunotherapy, unless treated with doses of genetically modified autologous or allogeneic T-cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04726787
Start Date
August 18 2022
End Date
June 30 2025
Last Update
December 9 2024
Active Locations (3)
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1
St James's University Hospital
Leeds, United Kingdom
2
Kings College Hospital
London, United Kingdom
3
Freeman Hospital
Newcastle, United Kingdom