Study on Acalabrutinib and Venetoclax, With or Without Obinutuzumab, Versus Chemoimmunotherapy for Untreated Chronic Lymphocytic Leukemia (CLL)

Sponsor: Acerta Pharma BV

Sponsor score: 0

ClinicalTrials ID:NCT03836261

Provider View

This clinical trial is testing the effectiveness and safety of a new combination of drugs, acalabrutinib and venetoclax, with or without obinutuzumab, compared to standard chemoimmunotherapy in patients with previously untreated Chronic Lymphocytic Leukemia (CLL).

Patient Parameters

Program Overview

The study aims to find out if the combination of acalabrutinib and venetoclax, with or without obinutuzumab, is more effective and safer than traditional chemoimmunotherapy for patients with CLL who have not received any prior treatment. Participants will be randomly assigned to one of three groups to receive different treatments and will be monitored throughout the study to assess the outcomes.

Description

This is a Phase 3 study conducted globally across multiple centers. It is designed to compare the effectiveness and safety of two new drug combinations against standard chemoimmunotherapy in patients with CLL who have not been treated before. Participants will be randomly placed into one of three groups: one group will receive acalabrutinib and venetoclax, another will receive acalabrutinib, venetoclax, and obinutuzumab, and the third group will receive standard chemoimmunotherapy. The study will include a screening phase, a treatment phase, and a follow-up phase to monitor the participants' health and response to the treatments.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older.
  • Must be in good general health with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
  • Must have a diagnosis of CLL that requires treatment according to specific medical criteria.
  • Must agree to use effective birth control throughout the study.

Exclusion Criteria

  • Have received any previous treatments specifically for CLL.
  • Have certain genetic mutations (del(17p) or TP53) associated with CLL.
  • Have CLL that has transformed into a more aggressive form of cancer or has spread to the central nervous system.
  • Have a history of a specific brain infection called progressive multifocal leukoencephalopathy (PML).
  • Have taken any experimental drugs within 30 days before starting the study.
  • Have had major surgery within 30 days before starting the study.
  • Have significant heart disease or have had a heart attack within the last 6 months.
  • Have digestive issues that affect the absorption of medication.
  • Have received a live vaccine within 28 days before starting the study.
  • Have a known infection with HIV or active hepatitis B or C.
  • Have allergies to the study drugs or their ingredients.
  • Have had a stroke or brain bleeding within 6 months before starting the study.
  • Have known bleeding disorders.
  • Are taking blood thinners like warfarin.
  • Female participants must not be pregnant or breastfeeding.
  • Are participating in another clinical trial at the same time.

Locations

FACILITYZIPCITYSTATE
Research Site90095Los AngelesCalifornia
Research Site90277Redondo BeachCalifornia
Research Site46804Fort WayneIndiana
Research Site67214WichitaKansas
Research Site40207LouisvilleKentucky
Research Site70056New OrleansLouisiana
Research Site21201BaltimoreMaryland
Research Site02215BostonMassachusetts
Research Site10021New YorkNew York
Research Site28204CharlotteNorth Carolina

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