NCT04726787

RadiothErapy priMIng for CAR-T

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Large B Cell Lymphoma approved to receive CD19 CAR-T cells as per their licensed indication. The trial will recruit 20 patients who have been approved to receive Tisagenlecleucel treatment and where the tumour is amendable to radiotherapy as per standard of care. Trial subjects (patients) during a 14 day screening phase will have their metabolic tumour burden assessed by PET-CT and bridging radiotherapy will be planned. Bridging radiotherapy will commence immediately after leukapheresis with dose adjustments according to disease burden and localisation. Disease areas requiring effective long-term control will receive full dose radiotherapy, 20 - 30Gy /5-15# and other areas will receive low dose radiotherapy, 4Gy / 2# for optimal tumour debulking and priming effects. Standard lymphodepletion will be given day -5 to day -3 followed by Tisagenlecleucel infusion on day 0. A window of 14-21 days will be left from last dose of radiotherapy and day 0. Patients will be followed up at 3 and 6 months after Tisagenlecleucel infusion for a minimum of 12 months.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
RADIATION	Bridging Radiotherapy	Bridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment

Timeline

• Start date: 2022-08-18
• Primary completion: 2023-07-05
• Completion: 2025-06-30
• First posted: 2021-01-27
• Last updated: 2024-12-09

Locations

3 sites across 1 country: United Kingdom