What side effects are associated with this type of intervention?

Common treatments for Mantle Cell Lymphoma, such as tafasitamab and lenalidomide, often have side effects including neutropenia, anemia, thrombocytopenia, and increased risk of infections. Lenalidomide, in particular, is associated with hematologic toxicities like neutropenia and thrombocytopenia, as well as non-hematologic effects such as fatigue, diarrhea, and rash. Tafasitamab, targeting CD19, can lead to infusion-related reactions and cytopenias. Patients undergoing these treatments should be closely monitored for these adverse effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Mantle Cell Lymphoma (MCL) that are similar to tafasitamab and lenalidomide. Brexucabtagene autoleucel, a CAR-T cell therapy targeting CD19, has shown high efficacy in relapsed or refractory MCL. Additionally, lenalidomide itself is FDA-approved for MCL, often used in combination with rituximab, an anti-CD20 monoclonal antibody, to enhance immune response and inhibit angiogenesis. These treatments reflect the ongoing efforts to target specific antigens on B-cells and modulate the immune system in MCL therapy.

What other types of research exist?

Promising novel alternatives for Mantle Cell Lymphoma patients include: 1) Bendamustine combined with Rituximab, which has shown high anti-lymphoma activity and favorable toxicity profiles. 2) Bortezomib, a proteasome inhibitor, combined with Rituximab and Dexamethasone, which has demonstrated significant activity in relapsed and refractory MCL. 3) Cladribine combined with Rituximab and Cyclophosphamide, which has shown increased response rates and prolonged survival in heavily pretreated patients.

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Immunomodulatory agents

Tafasitamab + Lenalidomide for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Anita Kumar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a combination of two drugs, tafasitamab and lenalidomide, can help patients with Mantle Cell Lymphoma who haven't responded to other treatments or whose cancer has come back. Tafasitamab targets cancer cells, and lenalidomide helps the immune system fight the cancer.

Who is the study for?

Adults with relapsed or refractory Mantle Cell Lymphoma who've had at least one prior treatment including a BTKi, and can become pregnant must follow strict contraception guidelines. Participants need to have adequate organ function, no concurrent cancers requiring active therapy (with some exceptions), no significant infections or liver disease, and not be pregnant.

What is being tested?

The study is testing the effectiveness of combining two drugs, Tafasitamab and Lenalidomide, for treating Mantle Cell Lymphoma that has returned after treatment or did not respond to previous treatments. The trial requires participants to undergo various assessments like bone marrow biopsy and imaging studies.

What are the potential side effects?

Potential side effects include blood clots which require prophylaxis, increased risk of infection due to lowered immune defenses, possible liver issues indicated by elevated enzyme levels in tests, fatigue from anemia if platelet counts are low, and digestive disturbances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of 12 cycles of treatment (each cycle is 28 days) or at treatment discontinuation, whichever comes first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate/ORR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Mantle Cell LymphomaExperimental Treatment2 Interventions

Participants have a diagnosis of Mantle Cell Lymphoma have previously failed or could not tolerate Bruton's tyrosine kinase inhibitors/BTKi

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tafasitamab

2016

Completed Phase 3

~630

Lenalidomide

2005

Completed Phase 3

~2240

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mantle Cell Lymphoma (MCL) include agents like tafasitamab and lenalidomide. Tafasitamab is a monoclonal antibody that targets CD19 on B-cells, leading to cell death through antibody-dependent cellular cytotoxicity and phagocytosis. Lenalidomide enhances the immune response by stimulating T-cells and natural killer cells, and inhibits angiogenesis, which is essential for tumor growth. These mechanisms are significant for MCL patients as they directly target malignant B-cells and boost the immune system's ability to combat the cancer, potentially improving treatment efficacy.