Glofitamab Combined With Pirtobrutinib in Relapsed/Refractory Patients with Mantle Cell Lymphoma Followed by an Extension in Treatment Naïve Patients (PLATO)

Conditions

Mantle Cell Lymphoma (MCL)

Brief summary

The primary endpoint is progression-free survival status 24 months from treatment start and will be analyzed by cohort and stratum (cohort A, cohort B high-risk, and cohort B standard-risk). Analysis will be performed on a modified ITT population: eligible patients who received at least one dose of any IMP.

Detailed description

Progression free survival time from treatment start, Complete remission rate (CR) and overall response rate (ORR: CR, PR) 8 months from treatment start (after completion of glofitamab-treatment, prior to cycle 13) and approximately 24 months (prior to cycle 30) from treatment start., Rate of PET negative CR (complete metabolic response rate, Lugano criteria) 8 months from treatment start (after completion of glofitamab-treatment prior to cycle 13) and 24 months (prior to cycle 30) from treatment start, Best response, time to best response, time to first response from treatment start, Duration of response., Duration of CR, Overall survival (OS) time from treatment start, Safety: adverse events, serious adverse events, toxicities (CTCAE v5.0 and ASTCT 2019 for CRS/ICANS)

Related papers

No related papers found yet.

Interventions

DRUGOBINUTUZUMAB

DRUGColumvi 10 mg concentrate for solution for infusion

DRUGPIRTOBRUTINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is progression-free survival status 24 months from treatment start and will be analyzed by cohort and stratum (cohort A, cohort B high-risk, and cohort B standard-risk). Analysis will be performed on a modified ITT population: eligible patients who received at least one dose of any IMP.	—

Secondary

Measure	Time frame
Progression free survival time from treatment start, Complete remission rate (CR) and overall response rate (ORR: CR, PR) 8 months from treatment start (after completion of glofitamab-treatment, prior to cycle 13) and approximately 24 months (prior to cycle 30) from treatment start., Rate of PET negative CR (complete metabolic response rate, Lugano criteria) 8 months from treatment start (after completion of glofitamab-treatment prior to cycle 13) and 24 months (prior to cycle 30) from treatment start, Best response, time to best response, time to first response from treatment start, Duration of response., Duration of CR, Overall survival (OS) time from treatment start, Safety: adverse events, serious adverse events, toxicities (CTCAE v5.0 and ASTCT 2019 for CRS/ICANS)	—

Measure

Time frame

Progression free survival time from treatment start, Complete remission rate (CR) and overall response rate (ORR: CR, PR) 8 months from treatment start (after completion of glofitamab-treatment, prior to cycle 13) and approximately 24 months (prior to cycle 30) from treatment start., Rate of PET negative CR (complete metabolic response rate, Lugano criteria) 8 months from treatment start (after completion of glofitamab-treatment prior to cycle 13) and 24 months (prior to cycle 30) from treatment start, Best response, time to best response, time to first response from treatment start, Duration of response., Duration of CR, Overall survival (OS) time from treatment start, Safety: adverse events, serious adverse events, toxicities (CTCAE v5.0 and ASTCT 2019 for CRS/ICANS)

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Countries

Denmark, Germany, Norway, Spain, Sweden

Outcome results

None listed