RadiothErapy priMIng for CAR-T

NCT04726787 | Active Not Recruiting DMC

• 1 other identifier: UCL/137861
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients starting lymphodepletion on the planned start date without delay

  To evaluate whether there is any delay in patients starting lymphodepletion

  From planned start date of lymphodepletion until actual start date of lymphodepletion, assessed up to 2 weeks

Secondary Outcomes (11)

• Best overall response after Tisagenlecleucel infusion as per International Working Group 2014 criteria

  After Tisagenlecleucel infusion through to study completion, an average of 24 months

• Overall response rate at 3 months and 6 months after Tisagenlecleucel infusion

  At 3 and 6 months after Tisagenlecleucel infusion

• Complete metabolic response at 3 months and 6 months after Tisagenlecleucel infusion

  At 3 and 6 months after Tisagenlecleucel infusion

• Duration of response

  From initial response until the date of first documented disease progression, assessed up to 24 months

• Median progression free survival and progression free survival at 12 months

  12 months after Tisagenlecleucel infusion

Study Arms (1)

Bridging Radiotherapy

EXPERIMENTAL

Disease areas requiring effective long-term control will receive full-dose radiotherapy (20-30Gy/5-15#); other areas will receive low dose (4Gy/2#)

Radiation: Bridging Radiotherapy

Interventions

Bridging Radiotherapy RADIATION

Bridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment

Bridging Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (3)

St James's University Hospital

Leeds, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andrea Kuhnl

  King's College Hospital NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 27, 2021
• Study Start: August 18, 2022
• Primary Completion: July 5, 2023
• Study Completion: June 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

GB (3)