Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
6 participants
INTERVENTIONAL
2022-08-18
2025-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bridging Radiotherapy
Disease areas requiring effective long-term control will receive full-dose radiotherapy (20-30Gy/5-15#); other areas will receive low dose (4Gy/2#)
Bridging Radiotherapy
Bridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment
Interventions
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Bridging Radiotherapy
Bridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
University College, London
OTHER
Responsible Party
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Principal Investigators
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Andrea Kuhnl
Role: STUDY_CHAIR
King's College Hospital NHS Trust
Locations
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St James's University Hospital
Leeds, , United Kingdom
Kings College Hospital
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Countries
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Other Identifiers
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UCL/137861
Identifier Type: -
Identifier Source: org_study_id