Phase 3, interventional, multicentre, open label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ)

Conditions

Splenic marginal zone lymphoma

Brief summary

Investigator-assessed PFS rate at 3 years according to the Lugano 2014 criteria

Detailed description

Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Lugano 2014 criteria., Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Lugano 2014 criteria, Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Matutes criteria, Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Matutes criteria, Investigator-assessed Time to next anti-lymphoma treatment (TTNT) according to the Lugano 2014 criteria, Investigator-assessed duration of response according to the Lugano 2014 criteria, Overall Survival according to the Lugano 2014 criteria, Analysis of type and severity of adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

Related papers

No related papers found yet.

Interventions

DRUGZanubrutinib

DRUGTruxima 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Investigator-assessed PFS rate at 3 years according to the Lugano 2014 criteria	—

Secondary

Measure	Time frame
Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Lugano 2014 criteria., Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Lugano 2014 criteria, Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Matutes criteria, Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Matutes criteria, Investigator-assessed Time to next anti-lymphoma treatment (TTNT) according to the Lugano 2014 criteria, Investigator-assessed duration of response according to the Lugano 2014 criteria, Overall Survival according to the Lugano 2014 criteria, Analysis of type and severity of adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0	—

Measure

Time frame

Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Lugano 2014 criteria., Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Lugano 2014 criteria, Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Matutes criteria, Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Matutes criteria, Investigator-assessed Time to next anti-lymphoma treatment (TTNT) according to the Lugano 2014 criteria, Investigator-assessed duration of response according to the Lugano 2014 criteria, Overall Survival according to the Lugano 2014 criteria, Analysis of type and severity of adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

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Countries

Austria, Denmark, France, Italy, Norway, Spain, Sweden

Outcome results

None listed