Status:
ACTIVE_NOT_RECRUITING
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
Lead Sponsor:
AstraZeneca
Conditions:
Untreated Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
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 Lymph...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04075292
Start Date
January 20 2020
End Date
January 1 2027
Last Update
November 21 2025
Active Locations (46)
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1
Research Site
Beijing, China, 100191
2
Research Site
Changchun, China, 130021
3
Research Site
Changsha, China, 410013
4
Research Site
Changzhou, China, 272100