Clinical trial · Observational
Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina
An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina
NCT03059251CI-TRIAL-00044718completedClinicalTrials.gov clinicaltrialsProvenance
- 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 observational study aims to study the effectiveness and safety of Obinutuzumab in common clinical practice settings in Argentina. The study population comprises all patients with chronic lymphocytic leukemia (CLL) that have received the indication for treatment with Obinutuzumab as per routine clinical practice.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Biological | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Obinutuzumab
- description
- All participants with chronic lymphocytic leukemia (CLL) who have received the indication for treatment with Obinutuzumab, as per routine clinical practice in Argentina.
- interventionNames
- Biological: Obinutuzumab
Primary outcomes (2)
- measure
- Overall Response Rate
- timeFrame
- Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
- description
- Overall response rate was defined as percentage of participants with complete response (CR) or partial response (PR). CR was defined as peripheral blood lymphocytes below 4 x 10\^9/liter (L), absence of significant lymphadenopathy, no hepatomegaly, no splenomegaly, absence of disease or B symptoms, neutrophils \>1.5 x 10\^9/L, platelets \>100 x 10\^9/L, hemoglobin \>11 grams/deciliter (g/dl) and bone marrow at least normocellular for age. PR was defined as \>=50% decrease in peripheral blood lymphocyte count, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver enlargement and/or \>/=50% reduction of spleen enlargement, plus at least one of the following: neutrophils \>1.5 x 10\^9/L or \>/=50% increase, or platelets \>100 x 10\^9/L or ≥50% increase, or hemoglobin 11 g/dl or \>/=50% increase. Overall response rate = CR + PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have received at least one dose of Obinutuzumab as per local label and clinical practice. Exclusion Criteria: * Included in clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.