Phase 2 Study of Tafasitamab with Lenalidomide and Rituximab for Untreated Follicular and Marginal Zone Lymphoma

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40

ClinicalTrials ID:NCT06792825

This clinical trial is testing a new combination of drugs, tafasitamab, lenalidomide, and rituximab, to see if they are safe and effective for patients with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who have not received any prior treatment.

Patient Parameters

Program Overview

The study is designed to evaluate the safety and effectiveness of adding tafasitamab to the standard treatment of rituximab and lenalidomide for patients with two types of lymphoma: follicular lymphoma (FL) and marginal zone lymphoma (MZL). Each type of lymphoma will be studied separately. Patients will be informed about the study and will need to sign a consent form before starting treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with marginal zone lymphoma or CD20+ follicular lymphoma at stage 1, 2, or 3a.
  • Have not received any previous systemic treatment for lymphoma.
  • Need treatment due to:
    • Large tumor mass over 7 cm or multiple sites over 3 cm.
    • Symptoms like unexplained fever, night sweats, or significant weight loss.
    • Tumor affecting vital organs or causing issues like large spleen or fluid buildup.
    • High-risk follicular lymphoma based on specific scoring.
  • Have adequate organ function as confirmed by recent tests.
  • Agree to use effective birth control during and after treatment if of childbearing potential.
  • Able to take preventive blood clot medication while on lenalidomide.
  • Willing to provide written consent to participate in the study.

Exclusion Criteria

  • Active hepatitis B or C infection.
  • HIV positive.
  • Previous use of lenalidomide.
  • Other cancers unless disease-free for 5 years.
  • Severe nerve damage.
  • Uncontrolled illness or active infection.
  • History of lymphoma in the brain or spinal cord.
  • Not willing to take blood clot prevention medication.
  • Recent serious blood clots.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential must have negative pregnancy tests before starting lenalidomide and agree to regular pregnancy testing during treatment.

Locations

FACILITYZIPCITYSTATE
Masonic Cancer Center55455MinneapolisMinnesota

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