Tafasitamab + Lenalidomide + Rituximab for Follicular & Marginal Zone Lymphoma

(InMIND Trial)

Recruiting in Palo Alto (17 mi)

+318 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 is testing if adding two drugs, tafasitamab and lenalidomide, to an existing treatment (rituximab) is more effective than just adding one drug (lenalidomide) for patients with certain types of lymphoma that have returned or not responded to treatment. The drugs aim to better target and destroy cancer cells while boosting the body's immune response against the cancer. Lenalidomide has shown activity in various lymphoma subtypes, including diffuse large B-cell lymphoma, and is often combined with rituximab for enhanced efficacy.

Research Team

Eligibility Criteria

This trial is for adults with relapsed/refractory Follicular Lymphoma or Marginal Zone Lymphoma who've had prior anti-CD20 immunotherapy or chemo-immunotherapy. Participants must be able to take blood clot prevention meds, not be pregnant or breastfeeding, and have no major heart issues, active infections, HIV/HCV/HBV, CNS lymphoma involvement, or recent other lymphoma treatments.

Inclusion Criteria

My lymphoma is confirmed to be of a specific type and grade.

I am willing to take medication to prevent blood clots as advised.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I have been treated with lenalidomide and rituximab together.

I am currently fighting an infection in my body.

I have been diagnosed with congestive heart failure.

Treatment Details

Interventions

• Lenalidomide (Anti-tumor antibiotic)
• Placebo (Chemotherapy)
• Rituximab (Monoclonal Antibodies)
• Tafasitamab (Monoclonal Antibodies)

Trial Overview The study tests if adding Tafasitamab to the combination of Lenalidomide and Rituximab improves outcomes for patients compared to a placebo plus Lenalidomide and Rituximab. It's a Phase 3 trial where participants are randomly assigned to either the drug group or placebo group without knowing which one they're in.

Participant Groups

Group I: Arm A : tafasitamab + rituximab + lenalidomide Experimental Treatment 3 Interventions

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Group II: Arm B : placebo+rituximab+lenalidomide Placebo Group 3 Interventions

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School