Trials / Terminated
TerminatedNCT04342117
Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL
PI3K-Inhibitor Registry Study: Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 2 (actual)
- Sponsor
- SecuraBio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Lymphoma, Small Lymphocytic
- Lymphoma
- Lymphoma, Non-Hodgkin
- Chronic Lymphocytic Leukemia
- Follicular Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | duvelisib | 25 mg BID, 15 mg BID |
| DRUG | PI3K inhibitor | FDA approved PI3K inhibitors |
Timeline
- Start date
- 2020-04-23
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2020-04-10
- Last updated
- 2021-03-17
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04342117. Inclusion in this directory is not an endorsement.