A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

What this study is about

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Primary outcome measures

FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First — up to approximately 34 months
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First — up to 2 years

Who can take part

SexAllAge18 Years to no upper limitHealthy volunteersNo

Inclusion

* Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL * Willingness to avoid pregnancy or fathering children * In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin) * Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy * Documented relapsed, refractory, or PD after treatment with systemic therapy * ECOG performance status of 0 to 2

Exclusion

* Women who are pregnant or breastfeeding. * Any histology other than FL and MZL or clinical evidence of transformed lymphoma * Prior non-hematologic malignancy * Congestive heart failure * HCV positivity, chronic HBV infection or history of HIV infection * Active systemic infection * CNS lymphoma involvement * Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1 * Prior use of lenalidomide in combination with rituximab

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites

Acıbadem Maslak Hospital, Istanbul

Also running at 260 other sites in 28 countries.

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

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