Clinical trial · Interventional
RadiothErapy priMIng for CAR-T
NCT04726787CI-TRIAL-00083457REMITactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bridging Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bridging Radiotherapy
- description
- Disease areas requiring effective long-term control will receive full-dose radiotherapy (20-30Gy/5-15#); other areas will receive low dose (4Gy/2#)
- interventionNames
- Radiation: Bridging Radiotherapy
Primary outcomes (1)
- measure
- Percentage of patients starting lymphodepletion on the planned start date without delay
- timeFrame
- From planned start date of lymphodepletion until actual start date of lymphodepletion, assessed up to 2 weeks
- description
- To evaluate whether there is any delay in patients starting lymphodepletion
Secondary outcomes (11)
- measure
- Best overall response after Tisagenlecleucel infusion as per International Working Group 2014 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent 2. Age ≥ 18 years 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 0-1 8. Disease accessible for repeat biopsies (Selected patients only) 9. Disease amenable to radiotherapy as assessed by the treating clinical oncologist 10. Willing and able to comply with the requirements of the protocol, including contraceptive advice as per the protocol Exclusion Criteria: 1. Prior radiotherapy at location/dose that would interfere with application of radiotherapy 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.