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

Stopped early

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

In brief

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.

Key facts

Study ID

NCT04342117

Run by

SecuraBio

People needed

2

Starts

2020-04-23

Expected to finish

2020-12-31

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Not applicable

Where it is running

• CARTI Cancer Center — Little Rock, Arkansas, United States
• Joliet Oncology-Hematology Associates, LTD — Joliet, Illinois, United States
• Goshen General Hospital — Goshen, Indiana, United States
• McFarland Clinic,PC — Ames, Iowa, United States
• St. Agnes Hospital — Baltimore, Maryland, United States
• Regional Cancer Care Associates LLC — Bethesda, Maryland, United States
• Hattiesburg Clinic, PA — Hattiesburg, Mississippi, United States
• Capital Region Medical Center — Jefferson City, Missouri, United States
• Oncology Hematology Associates — Springfield, Missouri, United States
• NY Cancer and Blood Specialists — Port Jefferson Station, New York, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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