follicular lymphoma (FL) and marginal zone lymphoma (MZL) MedDRA version: 24.0 Level: LLT Classification code 10080213 Term: In situ follicular lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10076596 Term: Marginal zone lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Minjuvi
Product Name: Tafasitamab
Product Code: MOR208
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TAFASITAMAB
Current Sponsor code: MOR208
C
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Male and female participants at least 18 years of age who have a histologically confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL as assessed locally; expression of CD19+ and CD20+ on lymphoma cells must be documented for all participants, FL and MZL, prior to randomization. * Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance. * Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy (a participant in remission [in CR or PR] after the last prior treatment line would not be eligible). * Willingness to avoid pregnancy or fathering children Please refer to section 5.1 of the protocol for the full list of inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 352 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 266
Exclusion criteria
Exclusion criteria: * Women who are pregnant or breastfeeding. * History of or current histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment. * History of radiation therapy to = 25% of the BM for other diseases. * Active systemic infection. * Participants in a severely immunocompromised state. * Known CNS lymphoma involvement. Please refer to section 5.2 of the protocol for the full list of exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab to the efficacy of placebo and lenalidomide in addition to rituximab in participants with relapsed/ refractor (R/R) FL.;Secondary Objective: * To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab versus placebo and lenalidomide in addition to rituximab in the overall population (FL and MZL) * To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab versus placebo and lenalidomide in addition to rituximab in the FL population.;Primary end point(s): PFS by investigator (INV) assessment in the FL population, using Lugano 2014 criteria (Cheson et al 2014). PFS is defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.;Timepoint(s) of evaluation of this end point: The primary analysis will be performed after approximately 174 PFS events based on INV are observed in the FL population in the full analysis set | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * PFS by INV assessment in the overall population (FL and MZL populations). * PET-CR rate at EOT (90 days after last treatment) by INV in the FL population. *OS in the FL population.;Timepoint(s) of evaluation of this end point: EOT (90 days after last treatment) | — |
Countries
Australia, Austria, Belgium, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed