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

  • End date
    Oct 31, 2024
  • participants needed
  • sponsor
Updated on 10 October 2022


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.


Patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (Arm A) or rituximab in combination with chlorambucil (Arm B). The primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation.

Condition Untreated Chronic Lymphocytic Leukemia
Treatment Rituximab, Chlorambucil, acalabrutinib
Clinical Study IdentifierNCT04075292
Last Modified on10 October 2022


Yes No Not Sure

Inclusion Criteria

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)
ECOG performance status of 0, 1, or 2
Diagnosis of CLL that meets published diagnostic criteria (Hallek 2018)
Active disease per IWCLL 2018 criteria that requires treatment
Adequate bone marrow function
Adequate renal and hepatic function

Exclusion Criteria

Known detected del(17p) or TP53 mutation
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
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
Significant cardiovascular disease
Known history of infection with human immunodeficiency virus (HIV)
Serologic status reflecting active hepatitis B or C infection
Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Major surgical procedure within 30 days of first dose of study drug
Any prior CLL-specific therapies
Corticosteroid use >20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
For women only: breastfeeding or pregnant
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