Status:
TERMINATED
Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL
Lead Sponsor:
SecuraBio
Conditions:
Lymphoma, Small Lymphocytic
Lymphoma
Eligibility:
All Genders
18+ years
Brief 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/S...
Eligibility Criteria
Inclusion
- 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
- Not applicable
Key Trial Info
Start Date :
April 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04342117
Start Date
April 23 2020
End Date
December 31 2020
Last Update
March 17 2021
Active Locations (11)
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1
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
2
Joliet Oncology-Hematology Associates, LTD
Joliet, Illinois, United States, 60435
3
Goshen General Hospital
Goshen, Indiana, United States, 46526
4
McFarland Clinic,PC
Ames, Iowa, United States, 50010