Study on Acalabrutinib Combined with Venetoclax or Obinutuzumab for Untreated Chronic Lymphocytic Leukemia

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05336812

Provider View

This clinical trial is exploring whether combining acalabrutinib with either venetoclax or obinutuzumab can help reduce cancer in patients with chronic lymphocytic leukemia (CLL) who have not received any prior treatment.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with chronic lymphocytic leukemia (CLL) who have not been treated before. The trial is looking at how well acalabrutinib, when combined with either venetoclax or obinutuzumab, can shrink tumors and improve patient outcomes. Acalabrutinib works by blocking certain cells that help cancer grow. Venetoclax targets a protein that cancer cells need to survive, while obinutuzumab is an antibody that may stop cancer cells from growing and spreading. Patients will first receive acalabrutinib for 12 cycles, then be randomly assigned to receive either acalabrutinib with obinutuzumab or acalabrutinib with venetoclax for 6 more cycles.

Description

The main goal of this study is to see if adding venetoclax or obinutuzumab to acalabrutinib treatment can improve the rate of undetectable cancer in the bone marrow of patients with untreated chronic lymphocytic leukemia (CLL). Researchers will also look at the safety and overall response to this combination treatment, as well as how long patients remain free from disease progression and how long the treatment effects last.

Participants will be divided into two groups:

  • Group 1: Patients will take acalabrutinib by mouth twice a day and receive obinutuzumab through an IV on specific days during the treatment cycles.
  • Group 2: Patients will take acalabrutinib by mouth twice a day and venetoclax by mouth once a day during the treatment cycles.

Each treatment cycle lasts 28 days, and patients will continue treatment for up to 18 cycles unless the disease progresses or side effects become unacceptable. After completing the treatment, patients will have follow-up visits at 30 days and every 6 months for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to specific guidelines.
  • Have not received any prior treatment for CLL, except for certain allowed therapies like local radiation or specific medications for symptom control.
  • Meet criteria for treatment based on specific symptoms or disease progression, such as worsening anemia, large lymph nodes, or significant weight loss.
  • Have a performance status that allows for daily activities with some restrictions.
  • Have adequate bone marrow function unless affected by CLL.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must use effective contraception during and after treatment.
  • Willing to participate in all study procedures and provide informed consent.

Exclusion Criteria

  • Have high-risk disease features like certain genetic mutations.
  • Need to take medications that interfere with the study drugs.
  • Have active central nervous system involvement by cancer.
  • Have other serious health conditions that could affect study participation.
  • Have significant heart disease or recent heart events.
  • Cannot swallow pills or have digestive issues affecting medication absorption.
  • Have active infections requiring IV treatment.
  • Have a history of severe allergic reactions to study drugs.
  • Have uncontrolled bleeding disorders or autoimmune conditions.
  • Are pregnant or breastfeeding.
  • Have received live vaccines recently.
  • Are participating in another clinical trial.

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