A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
• Capable of giving signed informed consent
• Age 18 years or older
• Histologically confirmed diagnosis of DLBCL
• Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.
• Patients must have:
‣ relapsed and/or refractory disease
⁃ at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
⁃ received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy
⁃ Eastern Cooperative Oncology Group 0 to 2
• Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT
• Patients must meet the following laboratory criteria at screening:
‣ absolute neutrophil count ≥1.5 × 10\^9/L
⁃ platelet count ≥90 × 10\^9/L
⁃ total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
⁃ alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement
⁃ serum creatinine clearance ≥ 60 mL/minute
• Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy
• Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy)