Relapsed/Refractory Mantle Cell Lymphoma
Conditions
Brief summary
ORR (complete response [CR] + partial response [PR]) per the Lugano Classification per Independent Radiology Review Committee (IRRC) review
Detailed description
DOR, Best objective response (BOR), ORR as determined by study investigators, Progression-free survival, Overall survival, Incidence of adverse events (AEs) and clinically significant changes in laboratory values, Incidence of anti-CD19 CAR antibodies, Levels of anti-CD19 CAR T cells in blood, Levels of cytokines in serum, Changes over time in the EQ-5D scale score and visual analogue scale score, Changes over time in the EORTC-QLQ-C30 score (Cohort 3 only)
Interventions
DRUGCytarabine 20 mg/ml Solution for Injection or Infusion
DRUGHistergan Tablets
DRUGMesna Injection
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
DRUGPanadol 500 mg Film Coated Tablets
Sponsors
Kite Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (complete response [CR] + partial response [PR]) per the Lugano Classification per Independent Radiology Review Committee (IRRC) review | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR, Best objective response (BOR), ORR as determined by study investigators, Progression-free survival, Overall survival, Incidence of adverse events (AEs) and clinically significant changes in laboratory values, Incidence of anti-CD19 CAR antibodies, Levels of anti-CD19 CAR T cells in blood, Levels of cytokines in serum, Changes over time in the EQ-5D scale score and visual analogue scale score, Changes over time in the EORTC-QLQ-C30 score (Cohort 3 only) | — |
Countries
France, Germany, Netherlands, Spain
Outcome results
None listed