Study Comparing Acalabrutinib with Other Treatments for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Sponsor: Acerta Pharma BV

Sponsor score: 0

ClinicalTrials ID:NCT02970318

This clinical trial is testing the effectiveness of the drug acalabrutinib against other treatment options, including combinations of rituximab with idelalisib or bendamustine, in patients with chronic lymphocytic leukemia (CLL) who have already received treatment.

Patient Parameters

Program Overview

The purpose of this study is to compare how well acalabrutinib works against other treatment combinations for patients with chronic lymphocytic leukemia (CLL) who have been treated before. The study will look at how effective acalabrutinib is compared to rituximab combined with either idelalisib or bendamustine.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Good general health with an ECOG performance status of 0 to 2.
  • Diagnosed with chronic lymphocytic leukemia (CLL) that meets specific medical criteria.
  • Must have CLL with CD20-positive cells.
  • Active CLL that requires treatment based on specific medical guidelines, such as worsening anemia, large or growing lymph nodes, or significant symptoms like weight loss or fatigue.
  • Must have certain blood counts and organ function levels within specified limits.
  • Must have received at least one prior treatment for CLL.
  • Women and men who are sexually active must agree to use effective birth control during the study and for a specified time after the last dose of study drugs.
  • Willing to participate in all study procedures and able to swallow capsules.
  • Able to understand the study and provide informed consent.

Exclusion Criteria

  • Known cancer in the central nervous system or certain types of leukemia.
  • Uncontrolled autoimmune conditions affecting blood cells.
  • Previous treatment with certain cancer drugs like BCL-2 or BCR inhibitors.
  • Recent chemotherapy or other cancer treatments within 30 days before starting the study.
  • Use of high-dose steroids shortly before starting the study.
  • Previous stem cell transplant within 6 months or ongoing complications from it.
  • Significant heart disease or recent heart attack.
  • Digestive issues that affect medication absorption.
  • Recent live virus vaccination.
  • Active infections like HIV, hepatitis B, or hepatitis C.
  • Serious liver conditions or history of lung inflammation.
  • History of severe allergic reactions.
  • Recent stroke or bleeding disorders.
  • Use of certain medications that affect blood clotting or interact with study drugs.
  • Pregnant or breastfeeding women.
  • Participation in another clinical trial.
  • Certain blood clotting test results outside normal limits.

Locations

FACILITYZIPCITYSTATE
Research Site85224ChandlerArizona
Research Site93030OxnardCalifornia
Research Site30607AthensGeorgia
Research Site60435JolietIllinois
Research Site52403Cedar RapidsIowa
Research Site40353Mount SterlingKentucky
Research Site56303Saint CloudMinnesota
Research Site68506LincolnNebraska
Research Site08724BrickNew Jersey
Research Site10960NyackNew York

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