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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-23

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lymphoma, Small Lymphocytic Lymphoma Lymphoma, Non-Hodgkin Chronic Lymphocytic Leukemia Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Duvelisib

Patients who take duvelisib.

duvelisib

Intervention Type DRUG

25 mg BID, 15 mg BID

Other PI3K-inhibitors

Patients who take a PI3K-inhibitor other than duvelisib

PI3K inhibitor

Intervention Type DRUG

FDA approved PI3K inhibitors

Interventions

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duvelisib

25 mg BID, 15 mg BID

Intervention Type DRUG

PI3K inhibitor

FDA approved PI3K inhibitors

Intervention Type DRUG

Other Intervention Names

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Copiktra, VS-0145

Eligibility Criteria

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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)