Study on LP-168 and Obinutuzumab for Treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Its Variants

Sponsor: Zulfa Omer

Sponsor score: 0

ClinicalTrials ID:NCT06978088

Provider View

This clinical trial is testing a combination of two drugs, LP-168 and Obinutuzumab, to treat patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have already received treatment or have a specific genetic mutation. The study aims to find a safe dosage and see how well the treatment works in reducing cancer cells.

Patient Parameters

Program Overview

The study is designed to evaluate the safety and effectiveness of combining LP-168 and Obinutuzumab for patients with CLL/SLL who have been previously treated or have a specific mutation known as BTK T474I. The goal is to determine a safe dosage and gather initial data on how well this combination works in reducing cancer cells to undetectable levels. If successful, this could lead to larger studies. Patients will receive LP-168 daily for 12 cycles, with evaluations after 6 cycles. Obinutuzumab will be added from cycle 7 to 12. The study will assess the treatment's impact on cancer cell levels and overall response.

Description

This study involves two groups of patients: those who have been previously treated for CLL/SLL and those with a specific genetic mutation. The treatment plan includes taking LP-168 daily for 12 cycles. After 6 cycles, patients will undergo tests to evaluate their response, including blood tests, scans, and bone marrow biopsies. From cycle 7, patients will also receive Obinutuzumab. The study aims to see if the combination can reduce cancer cells to undetectable levels. Patients who achieve this may stop treatment, while others may continue with LP-168. The study will also monitor patients for any disease progression and allow continued treatment if beneficial.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CLL or SLL and needing treatment, even if some test results vary, as long as other tests support the diagnosis.
  • Must fit into one of two groups:
    • Group 1: Previously treated with at least one therapy for CLL/SLL, including BCL2 inhibitors, chemotherapy, or BTK inhibitors.
    • Group 2: Previously treated with BTK inhibitors and have a specific BTK mutation.
  • Age 18 or older.
  • Good overall health with a performance status score of 2 or less.
  • Adequate organ and bone marrow function, with specific blood count and liver function levels.
  • Women of childbearing potential and men must use effective birth control during the study and for 30 days after.
  • Women must have a negative pregnancy test before starting the study.
  • Men must not donate sperm during the study and for 30 days after.
  • Able to provide informed consent.

Exclusion Criteria

  • Active Richter's transformation.
  • Recent cancer treatments or investigational therapies within 14 days or 5 half-lives before starting the study.
  • Uncontrolled health conditions that make participation unsafe.
  • Need for blood thinners like warfarin.
  • Major surgery within 14 days before starting the study.
  • Recent use of certain medications or therapies that interact with the study drugs.
  • Consumption of grapefruit or certain fruits within 3 days before starting the study.
  • Need for certain acid-reducing medications that interfere with the study drugs.
  • Significant heart or cardiovascular issues.
  • Recent stroke or brain bleeding.
  • Recent stem cell transplant or ongoing immunosuppressive therapy.
  • Pregnant or breastfeeding women.
  • Digestive issues affecting drug absorption.
  • Known allergies to study drug components.
  • Active bleeding disorders.
  • Uncontrolled infections or immune system issues.
  • Recent history of other active cancers, with some exceptions for stable or treated cancers.

Locations

FACILITYZIPCITYSTATE
University of Cincinnati Medical Center45219CincinnatiOhio

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