Phase 2 Study of Glofitamab for Detecting and Treating Minimal Residual Disease in Patients with Large B-cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06670105

Provider View

This clinical trial is exploring whether the drug glofitamab can help prevent the return of large B-cell lymphoma (LBCL) in patients who have no visible signs of cancer after initial treatment but still have minimal residual disease (MRD). The study will also assess the safety of glofitamab.

Patient Parameters

Program Overview

The aim of this study is to find out if glofitamab can help stop large B-cell lymphoma (LBCL) from coming back in patients who have achieved complete remission (CR) after their first round of standard treatment but still test positive for minimal residual disease (MRD). Researchers will also look at how safe glofitamab is for these patients.

Description

The main goal of this study is to see if glofitamab can make minimal residual disease (MRD) undetectable in patients with large B-cell lymphoma (LBCL) who were MRD positive after their first treatment.

The study will also look at how long patients live without the disease getting worse (progression-free survival) and overall survival, as well as the safety of glofitamab for these patients.

Additionally, researchers will explore how the body responds to glofitamab and what might cause resistance to the treatment. They will also study how T-cells, a type of immune cell, react to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with specific types of large B-cell lymphoma.
  • Have received standard first-line chemotherapy treatment for the lymphoma.
  • Achieved complete remission according to specific medical criteria after initial treatment.
  • Tested positive for minimal residual disease (MRD) after first-line treatment.
  • Have a performance status score of 2 or less, indicating good overall health.
  • Must have adequate organ and bone marrow function, as shown by specific blood tests.
  • Must agree not to donate blood during the study and for 12 months after the last dose.
  • Women must not be breastfeeding and must use effective birth control during the study and for 2 months after the last dose.
  • Men must use effective birth control during the study and for 2 months after the last dose.
  • Must be willing to follow the study procedures and sign a consent form.

Exclusion Criteria

  • Have relapsed or refractory disease confirmed by scans.
  • Have not fully recovered from side effects of previous treatment, except for hair loss.
  • Have known central nervous system lymphoma or disease affecting the brain or spinal cord.
  • Have had another type of cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have any serious illness or medical condition that could affect safety or study results.
  • Have uncontrolled HIV, active hepatitis B or C, or any significant active infection.
  • Have a history of severe allergic reactions to similar treatments.
  • Have a history of immune system problems or are taking certain immune-suppressing medications.
  • Have significant heart disease or recent heart attack.
  • Have a history of stroke or seizure disorder.
  • Are pregnant or breastfeeding.
  • Have had a blood transfusion within 14 days before starting the study.
  • Have taken any investigational drugs within 28 days before starting the study.
  • Have had major surgery within 28 days or minor surgery within 3 days before starting the study.
  • Have received a live vaccine within 4 weeks before starting the study.
  • Are taking chronic corticosteroids at high doses.
  • Have previously been treated with certain types of antibodies.
  • Have an active autoimmune disease requiring treatment in the past 2 years.

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