Skip to main content

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

Trial Status: Active

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.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: IN_REVIEW

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

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.

Trial Phase Phase NA

Trial Type Not provided by clinicaltrials.gov

Lead Organization
Verastem Inc

  • Primary ID VS-0145-401
  • Secondary IDs NCI-2020-04295
  • Clinicaltrials.gov ID NCT04342117