Study on Bcl-2 Inhibitor GDC-0199 with Obinutuzumab and Ibrutinib for Treating Chronic Lymphocytic Leukemia

Sponsor: Kerry Rogers

Sponsor score: 0

ClinicalTrials ID:NCT02427451

Provider View

This clinical trial is testing a new combination of drugs, including GDC-0199, obinutuzumab, and ibrutinib, to see if they can effectively treat chronic lymphocytic leukemia (CLL) that has returned, not responded to treatment, or is newly diagnosed.

Patient Parameters

Program Overview

The study aims to find the best dose and assess the safety of the Bcl-2 inhibitor GDC-0199 when used with obinutuzumab and ibrutinib. These drugs work by blocking cancer cell growth and targeting specific cells. The goal is to see if this combination can be a better treatment option for patients with CLL that has relapsed, is refractory, or is previously untreated.

Description

The main goals of this study are to find a safe dose of venetoclax (GDC-0199) when combined with obinutuzumab and ibrutinib, and to see how well this combination works in treating CLL. Researchers will look at how many patients achieve a complete response with no detectable disease after 12 cycles of treatment. They will also measure overall response rates and how long patients stay free from disease progression. The study will involve taking blood samples to understand how the drugs work in the body and to identify any markers that predict response or resistance to treatment.

Participants will receive obinutuzumab through an IV on specific days for up to 8 cycles. Starting in the second cycle, they will take ibrutinib by mouth daily, and from the third cycle, they will also take GDC-0199 daily. Treatment will continue every 28 days for up to 14 cycles unless the disease progresses or side effects become unacceptable. After treatment, patients will have follow-up visits to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) according to specific medical criteria.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • For relapsed or refractory CLL:
    • Must have received at least one prior therapy.
    • Require treatment as determined by the study doctor.
    • Relapsed patients must have shown disease progression after a previous response to treatment.
    • Refractory patients must not have responded or relapsed within 6 months of the last treatment.
  • For newly diagnosed CLL (Phase II only):
    • Must have symptomatic disease as defined by specific criteria.
    • No prior chemotherapy, immunotherapy, or targeted therapy, except for certain symptom control treatments.
  • Meet specific blood count and organ function criteria.
  • Female participants must not be pregnant and must agree to use effective birth control methods during the study.
  • Male participants must agree to use effective birth control methods during the study and for at least 3 months after treatment.
  • Must be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

  • Have received chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 28 days before starting the study, unless using steroids for symptom control.
  • Currently taking other investigational drugs.
  • Have uncontrolled autoimmune blood disorders.
  • Have active transformation of CLL to a more aggressive form.
  • Have active involvement of the central nervous system by cancer.
  • Require certain blood thinners or have taken them within 7 days before starting treatment.
  • Have taken certain medications that affect drug metabolism within 7 days before starting treatment.
  • Have consumed grapefruit, Seville oranges, or star fruit within 3 days before starting treatment.
  • Have a history of severe allergic reactions to similar drugs.
  • Have certain genetic mutations or resistance to similar treatments.
  • Have active infections like HIV or hepatitis unless controlled.
  • Have significant heart disease or other serious health conditions.
  • Have had other active cancers within the past 3 years, except for certain treated skin cancers or in situ cancers.
  • Have received a live vaccine within 28 days before starting treatment.
  • Have difficulty swallowing pills or have conditions affecting digestion.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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