Diffuse Large B Cell LymphomaREMITNCT04726787
RadiothErapy priMIng for CAR-T
A study testing Bridging Radiotherapy in people with Diffuse Large B Cell Lymphoma, run by University College, London at 3 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Bridging Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 18 Aug 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St James's University Hospital
Leeds
Kings College Hospital
London
Freeman Hospital
Newcastle
About this study
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
Read the 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
- Being tested
- Bridging Radiotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridging RadiotherapyRadiation
Bridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment
| Study group | Role | What they receive |
|---|---|---|
| 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#) Receives: Radiation: Bridging Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients starting lymphodepletion on the planned start date without delay
To evaluate whether there is any delay in patients starting lymphodepletion
Measured: 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
Proportion of patients achieving a Complete Response (CR) or Partial Response (PR)
Measured: After Tisagenlecleucel infusion through to study completion, an average of 24 months
Overall response rate at 3 months and 6 months after Tisagenlecleucel infusion
Overall response rate after Tisagenlecleucel infusion
Measured: At 3 and 6 months after Tisagenlecleucel infusion
Complete metabolic response at 3 months and 6 months after Tisagenlecleucel infusion
Complete metabolic response after Tisagenlecleucel infusion
Measured: At 3 and 6 months after Tisagenlecleucel infusion
Duration of response
Time from date of first response confirmation to the first date of progressive disease confirmation
Measured: 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
Progression Free Survival after Tisagenlecleucel infusion
Measured: 12 months after Tisagenlecleucel infusion
Median event-free survival and event-free survival at 12 months
Event-free survival after Tisagenlecleucel infusion
Measured: 12 months after Tisagenlecleucel infusion
Median overall survival and overall survival at 12 months
Overall Survival after Tisagenlecleucel infusion
Measured: 12 months after Tisagenlecleucel infusion
Treatment emergent adverse events
Adverse events being reported during and after treatment
Measured: From start of Tisagenlecleucel infusion until 30 days post Tisagenlecleucel infusion
Incidence of grade 3 or higher cytokine release syndrome and immune effector cell associated neurotoxicity syndrome
Percentage of grade 3 or higher cytokine relapse syndrome and immune effector cell associated neurotoxicity syndrome events
Measured: From start of Tisagenlecleucel infusion through to study completion, an average of 24 months
Neutrophil levels at 1, 3, 6 months after Tisagenlecleucel infusion
Neutrophil counts to be reported after Tisagenlecleucel infusion
Measured: At 1, 3 and 6 months after Tisagenlecleucel infusion
Platelet levels at 1, 3, 6 months after Tisagenlecleucel infusion
Platelet counts to be reported after Tisagenlecleucel infusion
Measured: At 1, 3 and 6 months after Tisagenlecleucel infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start18 Aug 2022
- Primary completion5 Jul 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Andrea Kuhnl, Study chair, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726787
- Sponsor's protocol ID
- UCL/137861
- Acronym
- REMIT
- Status last verified
- Dec 2024
- First submitted
- 20 Jan 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RadiothErapy priMIng for CAR-T
- ClinicalTrials.gov ID
- NCT04726787
- Acronym / sponsor ID
- REMIT / UCL/137861
- Conditions
- Diffuse Large B Cell Lymphoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bridging Radiotherapy | Experimental | Radiation: Bridging RadiotherapyDisease areas requiring effective long-term control will receive full-dose radiotherapy (20-30Gy/5-15#); other areas will receive low dose (4Gy/2#) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridging RadiotherapyBridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment | Radiation | Bridging Radiotherapy |
Primary outcome
Percentage of patients starting lymphodepletion on the planned start date without delay
Time frame: From planned start date of lymphodepletion until actual start date of lymphodepletion, assessed up to 2 weeks
To evaluate whether there is any delay in patients starting lymphodepletion
11 secondary outcomes
Best overall response after Tisagenlecleucel infusion as per International Working Group 2014 criteria
Time frame: After Tisagenlecleucel infusion through to study completion, an average of 24 months
Overall response rate at 3 months and 6 months after Tisagenlecleucel infusion
Time frame: At 3 and 6 months after Tisagenlecleucel infusion
Complete metabolic response at 3 months and 6 months after Tisagenlecleucel infusion
Time frame: At 3 and 6 months after Tisagenlecleucel infusion
Duration of response
Time frame: 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
Time frame: 12 months after Tisagenlecleucel infusion
Median event-free survival and event-free survival at 12 months
Time frame: 12 months after Tisagenlecleucel infusion
Median overall survival and overall survival at 12 months
Time frame: 12 months after Tisagenlecleucel infusion
Treatment emergent adverse events
Time frame: From start of Tisagenlecleucel infusion until 30 days post Tisagenlecleucel infusion
Incidence of grade 3 or higher cytokine release syndrome and immune effector cell associated neurotoxicity syndrome
Time frame: From start of Tisagenlecleucel infusion through to study completion, an average of 24 months
Neutrophil levels at 1, 3, 6 months after Tisagenlecleucel infusion
Time frame: At 1, 3 and 6 months after Tisagenlecleucel infusion
Platelet levels at 1, 3, 6 months after Tisagenlecleucel infusion
Time frame: At 1, 3 and 6 months after Tisagenlecleucel infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Kuhnl study chair
King's College Hospital NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridging Radiotherapy in people with Diffuse Large B Cell Lymphoma, run by University College, London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients starting lymphodepletion on the planned start date without delay (time frame: From planned start date of lymphodepletion until actual start date of lymphodepletion, assessed up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.