Mantle Cell Lymphoma (MCL)
Conditions
Brief summary
Primary endpoint: Failure-free survival (FFS) from randomization. Failure events are defined as the earliest of the following: o Stable disease at the end of induction (Arm B, or Arm A if CAR-T-cells are not infused) or within 12 weeks from CAR-T-cell infusion (Arm A), o Progressive disease at or at any time after end of induction treatment, and o Death from any cause at any time
Detailed description
Progression-free survival (PFS) from randomization, Complete remission (CR) rate and overall response rate (ORR: CR, PR) approx. 6.5 months from randomization, Rate of PET negative CR (complete metabolic response rate, per Lugano criteria) approx. 6.5 months from randomization, PFS in responders approx. 6.5 months from randomization (landmark analysis), Best response within 2 years from randomization, Time to best response and time to first response from randomization, Overall survival (OS) from randomization, Safety: adverse events, serious adverse events, graded according to CTCAE
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Failure-free survival (FFS) from randomization. Failure events are defined as the earliest of the following: o Stable disease at the end of induction (Arm B, or Arm A if CAR-T-cells are not infused) or within 12 weeks from CAR-T-cell infusion (Arm A), o Progressive disease at or at any time after end of induction treatment, and o Death from any cause at any time | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) from randomization, Complete remission (CR) rate and overall response rate (ORR: CR, PR) approx. 6.5 months from randomization, Rate of PET negative CR (complete metabolic response rate, per Lugano criteria) approx. 6.5 months from randomization, PFS in responders approx. 6.5 months from randomization (landmark analysis), Best response within 2 years from randomization, Time to best response and time to first response from randomization, Overall survival (OS) from randomization, Safety: adverse events, serious adverse events, graded according to CTCAE | — |
Countries
Czechia, France, Germany, Netherlands, Spain