Phase II Study of Pirtobrutinib, Venetoclax, and Obinutuzumab for Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06967610

Provider View

This clinical trial is testing a combination of three drugs—pirtobrutinib, venetoclax, and obinutuzumab—to see if they can help control chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned after treatment.

Patient Parameters

Program Overview

The study aims to find out if the combination of pirtobrutinib, venetoclax, and obinutuzumab can effectively manage CLL/SLL that has come back after previous treatments. Researchers are particularly interested in how well this combination can reduce the presence of cancer cells in the bone marrow and blood, as well as the overall response and survival rates of patients.

Description

The main goal of this study is to see how many patients have no detectable cancer cells in their bone marrow after 13 cycles of treatment with the drug combination. Researchers will also look at how many patients have no detectable cancer cells in their blood at different points during the treatment. They will assess the overall response to the treatment, including complete and partial responses, and monitor how long patients live without the disease getting worse. The safety and side effects of the treatment will also be evaluated.

Eligibility Criteria

Exclusion Criteria

  • Patients whose disease worsened while on venetoclax treatment.
  • Patients with a history of or current Richter's syndrome.
  • Patients allergic to any of the study drugs.
  • Patients with known or suspected cancer spread to the brain or spinal cord.
  • Patients with a history of bleeding disorders or major bleeding events on previous treatments.
  • Patients who had a stroke or brain bleeding within the last 6 months.
  • Patients needing blood thinners like warfarin.
  • Patients who had major surgery within 4 weeks before starting the study.
  • Patients with significant health issues that could affect participation or study results.
  • Patients who had a stem cell transplant or CAR-T therapy within 60 days before the study.
  • Patients with uncontrolled autoimmune blood disorders.
  • Patients with severe heart conditions or irregular heartbeats.
  • Patients with prolonged QT interval on an EKG.
  • Patients with active hepatitis B or C infections.
  • Patients with uncontrolled infections or other active diseases.
  • Patients with HIV infection.
  • Patients with active CMV infection.
  • Patients who had a live vaccine within 28 days before the study.
  • Patients with conditions affecting the absorption of oral medications.
  • Patients with another active cancer unless in remission and with a life expectancy over 2 years.
  • Patients taking certain medications that affect liver enzymes or drug absorption.
  • Pregnant or breastfeeding women, or those planning to become pregnant or breastfeed during or shortly after the study.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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