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Anti-metabolites

Tafasitamab + Lenalidomide for Non-Hodgkin's Lymphoma

Tampa, FL

Phase 2

Recruiting

Led By Frederick Locke, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Patients must have adequate renal function

Must not have

Known cardiac atrial or cardiac ventricular lymphoma involvement

Detectable cerebrospinal fluid malignant cells, brain metastases, or active central nervous system (CNS) lymphoma after CAR T cell administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if a combination of two drugs, tafasitamab and lenalidomide, is safe and effective for treating Large B Cell Lymphoma in patients who

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Who is the study for?

This trial is for individuals with Large B Cell Lymphoma who have previously undergone axicabtagene ciloleucel treatment. Participants will be involved in the study for approximately 12 months.Check my eligibility

What is being tested?

The safety and effectiveness of combining two drugs, Tafasitamab and Lenalidomide, are being tested as a first salvage therapy option for patients with LBCL after initial treatment.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, blood cell count changes, fatigue, rash or itching skin, digestive issues like nausea or constipation, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My kidney function is normal.

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I have been diagnosed with a type of large B-cell lymphoma.

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My organs and bone marrow are functioning well.

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My liver is working well.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart is affected by lymphoma.

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I have cancer cells in my brain or spinal fluid after CAR T cell treatment.

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I have a history of brain or nervous system disorders.

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I have an infection that needs IV treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete Response Rate (CRR)

Secondary study objectives

Duration of Response (DoR)

Objectives Response Rate (ORR)

Progression Free Survival (PFS)

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: Tafasitamab and Lenalidomide TreatmentExperimental Treatment2 Interventions

Participants will receive the study drug, Tafasitamab, intravenously on a weekly basis for the first three 28-day cycles (Cycles 1-3) and then every 2 weeks starting at Cycle 4 onwards. Participants will take the study drug, Lenalidomide, once daily for 21 days out of each 28-day cycle for 6 cycles.

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