A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing The Efficacy And Safety Of Tafasitamab Plus Lenalidomide In Addition To R-Chop Versus R-Chop In Previously Untreated, High-Intermediate And High-Risk Patients With Newly-
Posted Date: Oct 26, 2021
- Investigator: Tahir Latif
- Specialties: Cancer, Lymphoma, Oncology
- Type of Study: Drug
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL. Efficacy will be determined by progression free survival as assessed by the investigator using the lugano response criteria for malignant lymphoma. There will be an experimental arm where Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles, and a placebo arm where Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles.
Criteria:
Ipi Status Of 3 To 5 (For Patients > 60 Years Of Age) Or Aaipi 2 To 3 (For Patients = 60 Years Of Age). Ecog Performance Status Of 0, 1, Or 2. Left Ventricular Ejection Fraction Equal To Or Greater Than Lower Limit Of Institutional Normal Range, Assessed
Keywords:
Phase 3, Lymphoma
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com