For Healthcare Professionals

Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

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About the study

This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Men and women: (a) ≥65 years of age OR (b) >18 and <65 years of age, provided that they meet at least one of the following criteria: (i) Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation (iwCLL guidelines) (ii) A score higher than 6 on the Cumulative Illness Rating Score-Geriatric (CIRS G)
  2. ECOG performance status of 0, 1, or 2
  3. Diagnosis of CLL that meets published diagnostic criteria (Hallek 2018)
  4. Active disease per IWCLL 2018 criteria that requires treatment
  5. Adequate bone marrow function
  6. Adequate renal and hepatic function

EXCLUSION CRITERIA

  1. Known detected del(17p) or TP53 mutation
  2. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (eg, Richter's transformation, PLL, or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia
  3. History of prior malignancy except for the following: (a) Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment
  4. Significant cardiovascular disease
  5. Known history of infection with human immunodeficiency virus (HIV)
  6. Serologic status reflecting active hepatitis B or C infection
  7. Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment
  8. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
  9. Major surgical procedure within 30 days of first dose of study drug
  10. Any prior CLL-specific therapies
  11. Corticosteroid use >20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions
  12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
  13. For women only: breastfeeding or pregnant
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Untreated Chronic Lymphocytic Leukemia

Age

18+

Phase

Phase 3

Participants needed

150

Est. Completion Date

Oct 2024

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04075292

Study number

D822BC00001

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