drugset / Trial / NCT06003179
Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2024-04-05
- Primary completion
- 2026-11
- Completion
- 2028-11
Outcome
Outcome not reported
Stopped (Enrollment): “recruitment challenges and sites who initially expressed interest declined.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |