Study on Tafasitamab and Lenalidomide for Relapsed Central Nervous System Lymphoma

Sponsor: James Rubenstein

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05351593

Provider View

This clinical trial is testing a combination of two drugs, Tafasitamab and Lenalidomide, to see if they can help treat patients with central nervous system lymphoma that has returned after previous treatments. The study also explores if Tafasitamab can help other drugs reach the brain more effectively.

Patient Parameters

Program Overview

This study is investigating whether a combination of Tafasitamab, an anti-CD19 antibody, and Lenalidomide, an immune-modulating drug, can effectively treat patients with central nervous system (CNS) lymphoma that has come back after previous treatments. Researchers are also exploring if Tafasitamab can help other drugs cross the blood-brain barrier, which could have important implications for treating brain-related conditions.

Description

The main goals of this study are to find the best dose of Lenalidomide when used with Tafasitamab and to see how well this combination works in treating relapsed CNS lymphoma. The study will also look at the side effects of the treatment and how it affects the cancer.

Researchers will explore how well Tafasitamab and Lenalidomide can penetrate the brain and spinal fluid, and how the combination affects the immune system and cancer cells. They will also study the relationship between the genetic makeup of the tumor and the patient's response to the treatment.

The study is divided into two phases. In Phase I, different doses of Lenalidomide will be tested with Tafasitamab to find the safest and most effective dose. In Phase II, the focus will be on how well the treatment works at the established dose. Participants will be monitored for side effects and overall health for up to a year after the last dose. They can continue the treatment until the cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Have relapsed primary or secondary CNS lymphoma, specifically diffuse large B-cell lymphoma (DLBCL) type, confirmed by medical tests.
  • May have systemic lymphoma or transformation from other types of lymphoma.
  • Cancer can be in the brain, spinal fluid, or eyes.
  • Be 18 years or older.
  • Expected to live more than 2 months.
  • Be in good general health with a performance status score of 0 or 1.
  • Have adequate organ function based on specific blood tests.
  • Be able to understand and sign a consent form.
  • If you have hepatitis B, the virus must be under control.
  • If you have hepatitis C, it must be treated and cured, or under control if still being treated.
  • Can have other cancers if they don't interfere with this study.
  • Must use effective birth control if of childbearing potential.
  • Must have had at least one prior treatment for CNS lymphoma.
  • Can have had previous stem cell transplants if certain conditions are met.

Exclusion Criteria

  • Have received cancer treatments recently (within 2-4 weeks depending on the type).
  • Have not recovered from side effects of previous treatments.
  • Are currently in another clinical trial.
  • Have a history of HIV infection.
  • Have CNS post-transplant lymphoproliferative disease (PTLD).
  • Are allergic to Lenalidomide or Tafasitamab.
  • Are pregnant or breastfeeding, or not using effective birth control if of childbearing potential.
  • Have had previous anti-CD19 therapies, including CAR-T therapy.
  • Have any serious medical conditions that could affect safety.

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