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Trial Details
Trial status:
In set-up (funded)
Recruitment start date:
Funder:
Novartis & Sanofi-Aventis
Sponsor:
UCL
Chief Investigator:
Dr Andrea Kuhnl
Recruitment target:
20
EudraCT number:
Contact details:
ctc.REMIT@ucl.ac.uk
Lay summary:
REMIT
RadiothErapy priMIng for CAR-T
Description
Design:

This is an open label, single arm phase IIa study investigating RT as preferred bridging modality prior to Tisagenlecleucel infusion in subjects with relapsed/refractory DLBCL approved to receive CD19 CAR-T cells as per their licenced indication.

Treatment:

Bridging Radiotherapy will start immediately after leukapheresis with dose adjustment according to metabolic tumour volume (MTV) and localisation : disease areas requiring effective long-term control will receive full-dose radiotherapy (20-30Gy/5-15#); other areas with receive low dose (4Gy/2#) for optimal tumour debulking and priming effects.

Lymphodepletion and CAR T-cell infusion will be given as per SmPC.

A treatment window of 14-21 days will be left between last dose of radiotherapy and Day 0 (day of CAR T-cell infusion)

Key inclusion/exclusion criteria:

Inclusion Criteria

1. Written informed consent

2. Age 18 years and over

3. Histologically proven DLBCL, including transformed follicular- or marginal zone lymphoma

4. Measurable disease on cross-sectional imaging that is at least 1.5cm in the longest diameter and measurable in two perpendicular dimensions

5. Relapsed/refractory after 2 or more standard immuno-chemotherapies

6. Approved to receive tisagenlecleucel as per the licenced indication

7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

8. Disease accessible for repeat biopsies (King's College Hospital patients only)

9. Disease amenable to RT as assessed by the treating clinical oncologist

10. Willing and able to comply with the requirements of the protocol, including contraceptive advice

Exclusion Criteria

1. Prior radiotherapy at a location or dose that would interfere with application of RT or outcome measures in this trial

2. Women who are pregnant or breast feeding

3. Previous therapy with any genetically modified autologous or allogeneic T-cell immunotherapy, unless treatment with doses of genetically modified autologous or allogeneic T-cell immunotherapy within an abandoned dosing cohort in a first in human dose-esclation phase I clinical trial







Duration of recruitment: 12 months
Aim
The aim of the study is to assess the feasibility of metabolic tumour burden-adapted bridging radiotherapy (RT) in patients planned for Tisagenlecleucel treatment.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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