Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untre… (NCT04075292) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
China155 participantsStarted 2020-01-20
Plain-language 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 Lymphocytic Leukemia.
Who can participate
Age range18 Years – 130 Years
SexALL
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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 system…
What they're measuring
1
Progression Free Survival (PFS) Assessed by BICR
Timeframe: Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months)