Evaluate the Safety and Efficacy 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 Lymphoma

ConditionDLBCL
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

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

Treatment groups

244 Participants
are divided into 2 treatment groups