Tafasitamab + Lenalidomide for Diffuse Large B-Cell Lymphoma
(frontMIND Trial)

Recruiting in Palo Alto (17 mi)

+407 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Incyte Corporation

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new treatment combining an antibody, an immune-boosting drug, and standard chemotherapy for high-risk patients with newly diagnosed aggressive lymphoma. The goal is to see if this combination works better than standard chemotherapy alone. Rituximab, when combined with standard chemotherapy, has shown significant improvements in response rates and survival for patients with aggressive lymphoma.

Eligibility Criteria

This trial is for adults with untreated CD20-positive DLBCL, a type of lymphoma. They must be suitable for R-CHOP therapy and have an ECOG performance status of 0-2, meaning they are fully active or at least ambulatory. Participants need proper heart function and agree to contraception if applicable. Those with certain other cancers, CNS involvement by lymphoma, significant health issues, infections like TB, or prior anti-lymphoma treatment aren't eligible.

Inclusion Criteria

I am considered a suitable candidate for R-CHOP treatment.

Diagnosis to treatment interval ≤ 28 days

I can take care of myself and perform daily activities.

+8 more

Exclusion Criteria

My lymphoma type is not specifically listed.

My cancer has spread to my brain.

I have received treatments for lymphoma before the start of this clinical trial.

+4 more

Participant Groups

The study tests the effectiveness and safety of adding tafasitamab plus lenalidomide to the standard R-CHOP regimen against R-CHOP alone in high-risk DLBCL patients. It's a phase 3 trial where participants are randomly assigned to either receive the new combination or placebo alongside their regular chemotherapy.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tafasitamab plus lenalidomide in addition to R-CHOPExperimental Treatment7 Interventions

Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles: Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle

Group II: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOPPlacebo Group7 Interventions

Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles: Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle Lenalidomide placebo: Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: