Strategy Change

This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.

Phase IV, multicenter, prospective observational study in a real world (RW) setting, designed to observe the utilization and effectiveness of PI3K-inhibitor treatment, and HRQoL of patients with CLL/SLL/FL outside the context of a clinical trial.

Inclusion Criteria:

• Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy

  • Patients previously treated with PI3K-inhibitors are eligible for this study if they:

    • Are restarting treatment with PI3K-inhibitor at enrollment, or
    • Restarted PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment

  • Patients newly treated with PI3K-inhibitors are eligible for this study if they:

    • Are starting treatment with PI3K-inhibitors at enrollment, or
    • Started on PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment

• ≥18 years of age at time consent is provided to participate in this study

• For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records

• Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF)

Exclusion Criteria:

• Not applicable

Approximately 200 patients with a clinical or pathological diagnosis of CLL/SLL or pathological diagnosis of FL, for whom the Investigator has decided PI3K-inhibitor treatment is the appropriate therapy will be enrolled