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.
Both FL and MZL are subtypes of Non-Hodgkin Lymphoma (NHL), a group of cancers of lymphocytes which are cells belonging to the immune system. In NHL, abnormal lymphocytes multiply uncontrollably to eventually result in tumors in the lymph nodes, the bone marrow, or other organs. FL and MZL are the most frequent types of indolent (slow growing) NHL. The average age at diagnosis is about 60 years.
Follicular lymphoma is the most common subtype of indolent NHL (70%), and actually accounts for 35% of all Non-Hodgkin Lymphoma (Dada 2019). Incidence rates vary by geographic regions, with a higher incidence reported in Western Europe and the United States.
Marginal zone lymphoma (MZL) is another subtype of indolent NHL which can affect lymph nodes, the spleen or extra nodal organs, particularly the gastrointestinal tract (Swerdlow 2016).
There are a number of tests and procedures that are used to diagnosis follicular lymphoma and marginal zone lymphoma. They may include a physical exam (with an evaluation of performance status and symptoms), blood and urine laboratory tests, imaging tests (PET/CT), and bone marrow/lymph node biopsies.
inMIND is a phase 3 clinical study investigating the safety and efficacy of a new combination treatment for patients with relapsed/refractory (R/R) follicular lymphoma (FL) Grade 1, 2, or 3a or with R/R marginal zone lymphoma (MZL). The investigational combination treatment includes tafasitamab, a molecule that targets CD19 protein found on the surface of certain blood cells, rituximab, a molecule that targets CD20, and lenalidomide, which modulates the immune system.
The study is recruiting people over 18 years old with relapsed/refractory (R/R) follicular lymphoma (FL) Grade 1, 2, or 3a or with R/R marginal zone lymphoma (MZL) who have been previously treated with at least 1 anti-CD20 antibody containing therapy (e.g., rituximab, obinutuzumab, or other).
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.
Inclusion Criteria
Exclusion Criteria
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: 14 months
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: Up to 6 years
Timeframe: 13 months