Clinical trial · Observational
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
NCT04342117CI-TRIAL-00050710REALterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategy Change
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Small Lymphocytic | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| duvelisib | Drug | Duvelisib | ALIAS |
| PI3K inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Duvelisib
- description
- Patients who take duvelisib.
- interventionNames
- Drug: duvelisib
- label
- Other PI3K-inhibitors
- description
- Patients who take a PI3K-inhibitor other than duvelisib
- interventionNames
- Drug: PI3K inhibitor
Primary outcomes (1)
- measure
- Event-Free Survival (EFS)
- timeFrame
- 2 years
- description
- Observe the effectiveness of the PI3K-inhibitor administered
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 applicableReferences
Publications (0)
Data not yet available
No reference posted for this study.