B-cell chronic lymphocytic leukemia Chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, B-CLL
Conditions
Interventions
None listed
Sponsors
Shibayama Hirohiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients aged 18 years or older at the time of obtaining consent 2)Japanese treatment-naive B-CLL patients who meet the WHO classification revised 5th edition (2023) 3)Patients who meet the criteria for initiating treatment set forth by the International Workshop on Chronic Lymphocytic Leukemia 4)Patients who are starting acalabrutinib + obinutuzumab treatment or acalabrutinib monotherapy 5)Patients who fully understand the study protocol and can give their own consent
Exclusion criteria
Exclusion criteria: 1) Patients with a history of systemic treatment for B-CLL (previous history of localized radiation therapy is acceptable) 2)Patients with a history of other malignant tumors. (However, basal cell carcinoma of the skin, squamous cell carcinoma, non-invasive cervical cancer, and non-invasive prostate cancer who received curative treatment shall be excluded. For other cancers, patients who underwent curative treatment by surgery or radiation therapy, etc. and have not received treatment for more than 2 years since then shall be excluded) 3)Patients with severe cardiovascular disease, such as symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to enrollment, or with Class 3 or 4 heart disease as defined by the New York Heart Association Functional Classification at the time of enrollment (Patients with controlled asymptomatic atrial fibrillation are eligible to enroll) 4)Patients with severe active infection 5)Patients with active hepatitis B or C infection (However, patients who are HBs/HBc antibody positive and HBs antigen negative may be enrolled. Patients who are HCV antibody positive may be enrolled only if their HCV-RNA test is negative.) 6)Female patients who are breastfeeding or pregnant 7)Female patients of childbearing potential, who do not agree to use highly effective contraception during acalabrutinib treatment 8)Other patients who the Principal Investigator in medical institution (Site Investigator) and the Sub Investigator deems inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discontinuation-free survival at 2 years after the start of acalabrutinib treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival at 2 years after treatment start 2) Details and incidence of adverse drug reactions that led to discontinuation of acalabrutinib treatment 3) Reasons for discontinuation/suspension/dose reduction of acalabrutinib and their incidence 4) Presence or absence of drugs administered to prevent infection during acalabrutinib administration and incidence of infection 5) Incidence of cardiovascular events, hemorrhagic events and second primary malignancy 6) Changes in lymphocyte counts up to 12 weeks after the start of acalabrutinib administration 7) Clinical response rate based on iwCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria | — |
Contacts
Public ContactHirohiko Shibayama
National Hospital Organization Osaka National Hospital
Outcome results
None listed