Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

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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.

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Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

2

Study ID:

NCT04342117

Recruitment Status:

Terminated

Sponsor:

SecuraBio

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There are 11 Locations for this study

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CARTI Cancer Center
Little Rock Arkansas, 72205, United States
Joliet Oncology-Hematology Associates, LTD
Joliet Illinois, 60435, United States
Goshen General Hospital
Goshen Indiana, 46526, United States
McFarland Clinic,PC
Ames Iowa, 50010, United States
St. Agnes Hospital
Baltimore Maryland, 21229, United States
Regional Cancer Care Associates LLC
Bethesda Maryland, 20817, United States
Hattiesburg Clinic, PA
Hattiesburg Mississippi, 39401, United States
Capital Region Medical Center
Jefferson City Missouri, 65101, United States
Oncology Hematology Associates
Springfield Missouri, 65807, United States
NY Cancer and Blood Specialists
Port Jefferson Station New York, 11776, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

2

Study ID:

NCT04342117

Recruitment Status:

Terminated

Sponsor:


SecuraBio

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