Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL (REAL)

Secura Bio

Status: Terminated

Conditions: Follicular Lymphoma; Lymphoma, Small Lymphocytic; Lymphoma; Chronic Lymphocytic Leukemia; Lymphoma, Non-Hodgkin

Treatments: Drug: PI3K inhibitor; Drug: duvelisib

Study type: Observational

Funder types: Industry

Identifiers

NCT04342117

VS-0145-401

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 2 patient groups

Duvelisib

Description:

Patients who take duvelisib.

Treatment:

Drug: duvelisib

Other PI3K-inhibitors

Description:

Patients who take a PI3K-inhibitor other than duvelisib

Treatment:

Drug: PI3K inhibitor