Phase 2 Study on Using Acalabrutinib and Venetoclax for Treating Relapsed CLL After Initial Treatment

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07024706

Provider View

This clinical trial is testing a combination of two drugs, acalabrutinib and venetoclax, to see if they are effective and safe for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned after initial treatment.

Patient Parameters

Program Overview

The study aims to find out if a combination of acalabrutinib and venetoclax can help patients with CLL or SLL who have relapsed after their first treatment. The trial will look at how well this new treatment works and its safety. Participants must have previously responded to their first treatment for at least two years before their cancer returned. The study will last up to five years for each participant and includes screening, treatment, and follow-up periods. Patients will be grouped based on their disease risk, determined by specific genetic markers.

Description

This study is exploring a new treatment option for patients with CLL or SLL whose cancer has returned after initial therapy. The focus is on using acalabrutinib and venetoclax as a second-line treatment to see if it can effectively manage the disease. Participants must have previously responded well to their first treatment, which included a combination of drugs, for at least two years before experiencing a relapse. The study will assess the overall response rate to this new treatment combination.

Participants will be involved in the study for up to five years, which includes a screening phase to determine eligibility, a treatment phase where they will receive the study drugs, and a follow-up phase to monitor their health and the treatment's effectiveness. Patients will be categorized into low or high-risk groups based on specific genetic factors related to their disease.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with CLL or SLL according to specific medical guidelines.
  • Previously treated with a specific combination of drugs for CLL/SLL and responded well for at least two years.
  • Must have certain genetic information available, such as IGHV mutation status and TP53 mutation status.
  • Must be in good general health with adequate organ and bone marrow function.
  • Must have an ECOG performance status of 0, 1, or 2, indicating they are fully active or have some limitations but are still able to care for themselves.

Exclusion Criteria

  • Any condition that makes participation in the study unsafe, according to the study doctor.
  • Significant heart or blood vessel disease.
  • Active bleeding disorders or history of bleeding problems.
  • Severe liver disease.
  • History of other cancers.
  • HIV positive.
  • History of a specific brain infection called progressive multifocal leukoencephalopathy (PML).
  • Active hepatitis B or C infection.
  • Recent use of high-dose corticosteroids.
  • Allergic reactions to the study drugs.
  • Need for certain medications that interact with the study drugs.
  • Use of blood thinners like warfarin.
  • Recent major surgery.

Locations

FACILITYZIPCITYSTATE
Research Site02215BostonMassachusetts
Research Site28204CharlotteNorth Carolina
Research Site28204CharlotteNorth Carolina
Research Site27705DurhamNorth Carolina
Research Site27103Winston-SalemNorth Carolina

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