Description:
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.
Title
- Brief Title: Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
D822BC00001
- NCT ID:
NCT04075292
Conditions
- Untreated Chronic Lymphocytic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
Acalabrutinib | | Acalabrutinib |
Rituximab | | Rituximab and Chlorambucil |
Chlorambucil | | Rituximab and Chlorambucil |
Purpose
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.
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 compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in
subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53
mutation.
Trial Arms
Name | Type | Description | Interventions |
---|
Acalabrutinib | Experimental | Acalabrutinib will be orally administered until disease progression or unacceptable toxicity | |
Rituximab and Chlorambucil | Active Comparator | Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles | |
Eligibility Criteria
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
Maximum Eligible Age: | 130 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival (PFS) |
Time Frame: | approximately 50 months |
Safety Issue: | |
Description: | Progression free survival is defined as time from randomization until progression or death due to any cause (whichever occurs first) |
Secondary Outcome Measures
Measure: | Objective response rate |
Time Frame: | approximately 50 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | approximately 50 months |
Safety Issue: | |
Description: | |
Measure: | Time to next treatment |
Time Frame: | approximately 50 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | approximately 50 months |
Safety Issue: | |
Description: | |
Measure: | Minimal residual disease negativity rate |
Time Frame: | approximately 50 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- Chronic Lymphocytic Leukemia
- Acalabrutinib
- Progression-free Survival
Last Updated
August 10, 2021