NCT04075292Active, not recruitingPhase 3
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
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
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 155 (actual)
- First submitted
- 19 Aug 2019
- Start date
- 20 Jan 2020
- Primary completion date
- 3 Jan 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT04075292
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 155
- From 20 Jan 2020 to the primary completion date, 3 Jan 2024
- 37 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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
Other illness
- 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
Age
- 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
Other
- 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
- For women only: breastfeeding or pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.