Clinical trial · Observational
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization. The study population comprises patients with approved local indications chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical practice after launch.
Conditions
Conditions (2)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| obinutuzumab | Biological | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- obinutuzumab
- description
- Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab.
- interventionNames
- Biological: obinutuzumab
Primary outcomes (5)
- measure
- Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)
- timeFrame
- from baseline until the end of the participant's observation period (up to approximately 8 years)
- measure
- Percentage of Participants with Unexpected AE/ADR
- timeFrame
- from baseline until end of the participant's observation period (up to approximately 8 years)
- measure
- Percentage of Participants with Expected ADR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Administered obinutuzumab under the approved indications in Korea at investigator's discretion * Previously untreated with obinutuzumab Exclusion Criteria: * Out-of locally approved indications, dosage, and administration * Pregnant women, breastfeeding women * Hepatic disease * Participate in other clinical trials
References
Publications (0)
Data not yet available