Clinical trial NCT04342117: Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL
Official title: PI3K-Inhibitor Registry Study: Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphoma, Small Lymphocytic
Lymphoma
Lymphoma, Non-Hodgkin
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2020-04-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 200 patients with a clinical or pathological diagnosis of CLL/SLL or pathological diagnosis of FL, for whom the Investigator has decided PI3K-inhibitor treatment is the appropriate therapy will be enrolled

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/SLL/FL outside the context of a clinical trial.

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

Primary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: 2 years
Secondary outcomes:
measure: Measurement of Quality of Life - EQ-5D
timeFrame: 2 years
measure: Measurement of Quality of Life - FACT-lym
timeFrame: 2 years
measure: Characterize patient characteristics initiating treatment with PI3K-inhibitors
timeFrame: 2 years
measure: Measure Time to Next Treatment (TTNT)
timeFrame: 2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, LTD
state: Illinois
city: Goshen
country: United States
facility: Goshen General Hospital
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic,PC
state: Iowa
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Bethesda
country: United States
facility: Regional Cancer Care Associates LLC
state: Maryland
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic, PA
state: Mississippi
city: Jefferson City
country: United States
facility: Capital Region Medical Center
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Port Jefferson Station
country: United States
facility: NY Cancer and Blood Specialists
state: New York
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
References: