Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of informed consent
Life expectancy ≥ 12 weeks
Biopsy-proven and histologically confirmed R/R large B cell lymphoma, including R/R DLBCL, transformation from FL, and R/R PMBCL.
Radiographically documented measurable disease as per Lugano response criteria (i.e. LDi > 1.5 cm that is FDG avid).
Disqualifiers
Persisting disease bulk (defined as ≥10 cm) on restaging imaging following bridging therapy.
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
History of Richter's transformation of CLL
History of allogeneic stem cell transplant
Trial design
Treatments tested in this trial
- Cyclophosphamide
- TLI
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov