Clinical trial · Observational
An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)
A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)
- 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 prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| rituximab [MabThera/Rituxan] | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- First line
- interventionNames
- Drug: Chemotherapy
- Drug: rituximab [MabThera/Rituxan]
- label
- Relapsed/refractory
- interventionNames
- Drug: Chemotherapy
- Drug: rituximab [MabThera/Rituxan]
Primary outcomes (1)
- measure
- Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
- timeFrame
- 3 years
Secondary outcomes (3)
- measure
- Efficacy (Response rate, duration of response, progression-free survival)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * B cell-lineage chronic lymphocytic leukaemia (B-CLL) * Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC * Informed consent to data collection Exclusion Criteria: * Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study * Any other tumour disease
References
Publications (0)
Data not yet available