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.
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 By Local Echocardiography Or Cardiac Multi-Gated Acquisition (Muga) Scan. Adequate Hematologic Function. Availability Of Archival Or Freshly Collected Tumor Tissue Sent For Retrospective Central Pathology Review. Agreement To Remain Abstinent (Refrain From Heterosexual Intercourse) Or Use Contraceptive Methods And Refrain From Breast Feeding And Donating Eggs; Agreement To Ongoing Pregnancy Testing During The Course Of The Study, And After Study Therapy Has Ended. No Other Histological Type Of Lymphoma According To Who 2016 Classification Of Lymphoid Neoplasms, E.G., Primary Mediastinal (Thymic) Large B-Cell Lymphoma, Burkitt's Lymphoma, Bcl, Unclassifiable, With Features Intermediate Between Dlbcl And Classical Hodgkin Lymphoma (Grey-Zone Lymphoma); Primary Effusion Lymphoma; Primary Cutaneous Dlbcl, Leg Type; Primary Dlbcl Of The Cns; Dlbcl Arising From Cll Or Indolent Lymphoma. No Systemic Anti-Lymphoma And/Or Investigational Therapy Prior To The Start Of C1d1, Except For Permitted Pre-Phase Treatment. No Contraindication To Any Of The Individual Components Of R-Chop, Including Prior Receipt Of Anthracyclines. No Known Cns Lymphoma Involvement. No Known Active Systemic Bacterial, Viral, Fungal, Or Other Infection At Screening, Including Patients With Suspected Active Or Latent Tuberculosis (As Confirmed By A Positive Interferon-Gamma Release Assay). No History Or Evidence Of Clinically Significant Cardiovascular, Cns And/Or Other Systemic Disease That In The Investigator's Opinion Would Preclude Participation In The Study Or Compromise The Patient's Ability To Give Informed Consent.
Phase 3, Lymphoma
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Uc Cancer Center