About this trial
This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom
Eligibility criteria
Qualifiers
18 Years and older.
One of the histologies of DLBCL confirmed by participated sites below with,not otherwise specified;T-cell/histiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.
Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.
Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.
Disqualifiers
Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.
Current or history of central nervous system (CNS) lymphoma.
Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
Primary mediastinal B-cell lymphoma.
Trial design
Treatments tested in this trial
- Tafasitamab
- Lenalidomide
- Gemcitabine
- Oxaliplatin
- Rituximab