Clinical trial · Observational
An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia
An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
- 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 will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.
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 |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab [Mabthera/Rituxan] | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- interventionNames
- Drug: rituximab [Mabthera/Rituxan]
Primary outcomes (1)
- measure
- infusion-related adverse events
- timeFrame
- data collection every 4-6 weeks for up to 6 months for each patient
Secondary outcomes (1)
- measure
- usage and applicability of 90-minute iv infusion in patients with CLL
- timeFrame
- data collection every 4-6 weeks for up to 6 months for each patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>/= 18 years of age * chronic lymphocytic leukemia treated with rituximab (MabThera) * rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles * informed consent to data collection Exclusion Criteria: * participation in an interventional clinical study
References
Publications (0)
Data not yet available