Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah (NCT06003179) | Clinical Trial Compass
WithdrawnPhase 1
Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah
Stopped: recruitment challenges and sites who initially expressed interest declined.
Canada0Started 2024-04-05
Plain-language summary
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 lymphodepletion (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 chimeric antigen receptor T (CAR T) cell therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years at the time of informed consent
✓. Life expectancy ≥ 12 weeks
✓. Biopsy-proven and histologically confirmed relapse/refractory (R/R) large B cell lymphoma, including Primary mediastinal B-cell lymphoma (PMBCL), R/R DLBCL and transformation from Follicular lymphoma (FL).
✓. Radiographically documented measurable disease as per Lugano response criteria (i.e. longest transverse diameter of a lesion (LDi) \> 1.5 cm that is \[18F\] fluorodeoxyglucose (FDG) avid).
✓. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
✓. Eligible for standard of care CAR T cell therapy, specifically, relapsed or refractory large B cell lymphoma after two or more lines of systemic therapy, and subjects must have received adequate first-line therapy including at a minimum:
✓. Patient is sufficiently stable to facilitate planned CAR T-cell therapy (e.g. not rapidly progressing on temporizing therapy, no significant compromise of vital organ functions (intubation, dialysis, requiring Intensive care unit (ICU)/vasopressor support)) and has good performance status
✓. Patient does not have active central nervous system (CNS) disease
Exclusion criteria
✕. 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
What they're measuring
1
Maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for chemo plus radiation as lymphodepletion
Timeframe: baseline through end of study completion, approximately 2 years