Study on Mosunetuzumab for Clearing Minimal Residual Disease in Chronic Lymphocytic Leukemia (CLL)

Sponsor: Inhye Ahn

Sponsor score: 0

ClinicalTrials ID:NCT07052695

Provider View

This clinical trial is testing the drug Mosunetuzumab, either alone or with a type of medication called a BTK inhibitor, to see if it can help clear remaining cancer cells in patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of Mosunetuzumab, a medication given alone or with a BTK inhibitor, in treating patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study aims to see if these treatments can help clear minimal residual disease, which means reducing the number of remaining cancer cells after initial treatment.

Description

This study involves giving Mosunetuzumab, either by itself or with a BTK inhibitor, to patients with CLL or SLL. If you are already taking a BTK inhibitor, you will continue with it while receiving Mosunetuzumab. If you have previously been treated with a BCL2 inhibitor, you will receive Mosunetuzumab alone. The treatment can last up to 17 cycles, which is about a year. If you achieve early clearance of minimal residual disease, you may stop Mosunetuzumab after 8 cycles, or about 6 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CLL or SLL according to 2018 guidelines.
  • Recently completed or currently undergoing treatment for CLL/SLL.
    • If on BTK inhibitor therapy, must have been on it for more than 12 months and at a stable dose for over 2 months.
    • If previously treated with a BCL2 inhibitor, must have completed this treatment less than 12 months before joining the study.
  • Detectable minimal residual disease in blood or bone marrow.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate organ and bone marrow function.
  • Women of childbearing potential must use effective contraception during treatment and for 3 months after.
  • Men must use contraception during treatment and for 1 month after, and refrain from donating sperm.
  • Able to take oral medications.
  • Willing to sign informed consent.

Exclusion Criteria

  • Large tumors or very high white blood cell counts.
  • Progressing CLL at the time of joining the study.
  • Recent treatment with certain therapies like CAR-T or radioimmunotherapy.
  • History of organ or stem cell transplants.
  • Significant side effects from previous treatments.
  • Known or suspected transformation to a more aggressive form of cancer.
  • History of bleeding disorders or certain brain conditions.
  • Serious heart or lung diseases.
  • Significant liver disease or other cancers with a short life expectancy.
  • Taking other investigational drugs or high doses of steroids.
  • Recent major surgery or infections.
  • Known allergies to study drugs.
  • Positive for HIV, active hepatitis B or C, or recent COVID-19 infection.
  • Pregnant or breastfeeding women.
  • Active autoimmune diseases or other conditions that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
Brigham & Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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