Phase 2 Study of Mosunetuzumab for Patients with Chronic Lymphocytic Leukemia (CLL) with Detectable Disease

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07566364

Provider View

This clinical trial is testing the effectiveness of a new drug, mosunetuzumab, in patients with chronic lymphocytic leukemia (CLL) who still have detectable disease after treatment with Bruton's tyrosine kinase inhibitors (BTKis).

Patient Parameters

Program Overview

The study aims to see if mosunetuzumab, a drug that targets specific proteins on cancer cells, can help eliminate remaining cancer cells in patients with CLL who have been on BTKi therapy for at least 6 months without signs of disease progression.

Description

The main goal of this study is to determine if adding mosunetuzumab to ongoing BTKi therapy can help eliminate minimal residual disease (MRD) in the bone marrow of patients with CLL. Researchers will measure the success by checking the rate of undetectable MRD in the bone marrow after 17 cycles of mosunetuzumab treatment. They aim for a 50% success rate.

Secondary goals include assessing the safety of mosunetuzumab, the proportion of patients who can stop all treatment after 17 cycles, and the reduction of enlarged lymph nodes. The study will also evaluate overall response rates, progression-free survival, and overall survival. Researchers will monitor MRD levels in blood and bone marrow at various points and assess how these levels change over time.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to follow the study procedures.
  • Have received at least two previous treatments for CLL, including current BTKi therapy.
  • Have high-risk CLL/SLL, such as disease progression on previous treatments or specific genetic markers.
  • On continuous BTKi therapy for at least 12 months with detectable MRD in the bone marrow.
  • Good overall health with an ECOG performance score of 0 or 1.
  • Adequate blood cell counts and organ function.
  • Life expectancy of more than 6 months.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Men must agree to use condoms and avoid donating sperm during and after the study.

Exclusion Criteria

  • High disease burden, such as high lymphocyte count or large lymph nodes.
  • Pregnant or breastfeeding women.
  • Previous treatment with mosunetuzumab or similar drugs.
  • Recent stem cell transplant or active graft-versus-host disease.
  • Recent treatment with certain cancer therapies or vaccines.
  • History of severe allergic reactions to similar treatments.
  • Active infections or significant health conditions that could interfere with the study.
  • History of other cancers unless treated and in remission for at least 2 years.
  • Positive test for chronic hepatitis B or C, or other significant infections.
  • History of autoimmune diseases, unless well-controlled or in remission.

Locations

FACILITYZIPCITYSTATE
UT MD Anderson77030HoustonTexas

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