Mantle cell lymphoma (MCL)
Conditions
Interventions
1L CLL/SLL R/RCLL/SLL R/RMCL:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients shall be older than 18 years of age at diagnosis. 2.Patients diagnosed with mantle cell lymphoma (MCL) who have received at least one prior therapy; or patients diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who are treatment-naive or have received at least one prior therapy (consistent with the product labeling). 3.The investigator’s judgment (physician assessment) determines that acalabrutinib is suitable for the patient in routine clinical practice. 4.The patient or legal guardian shall be capable of reading, understanding and signing the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1.The investigator’s assessment (physician judgment) deems the patient unsuitable for acalabrutinib therapy. 2.Disease progression after prior treatment with other BTK inhibitors before acalabrutinib initiation. 3.Concurrent participation in another interventional clinical trial. 4.Females of childbearing potential must agree to use highly effective contraception throughout the study and for a minimum of 1 week after the last dose of study drug, and have a negative urine or serum pregnancy test within 7 days prior to the first dose of study drug. 5.No contraceptive requirements are mandated for non-sterilized male patients receiving acalabrutinib. 1) Infertile males refer to males who can provide highly effective contraception for their female partners taking acalabrutinib; 2) Males with known low sperm count (also referred to as subfertility) will not be categorized as infertile for the purposes of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment modalities, safety, patient characteristics, effectiveness (rwPFS/rwOS/rwRR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of adverse events (AE)/serious adverse events (SAE)/adverse events of special interest (AESI);Dosimetry;Patient characteristics;Rate of return on operating system;rwPFS rate;Overall rwRR;MRD negativity rate; | — |
Countries
China
Contacts
Public ContactYan Hua
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed