Clinical trial · Observational
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
NCT03289182CI-TRIAL-00049347completedClinicalTrials.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 is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.
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 |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MabThera | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- MabThera
- description
- Participants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years.
- interventionNames
- Drug: MabThera
Primary outcomes (1)
- measure
- Percentage of Participants with Adverse Events
- timeFrame
- Baseline up to Year 6
Secondary outcomes (2)
- measure
- Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL
- timeFrame
- Baseline up to Year 6
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Participants administered with MabThera subcutaneously within the approved indication in Korea * Participants previously untreated with MabThera subcutaneously Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg: * Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants * Previously untreated FL participants in combination with chemotherapy * Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy. * Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg: \- Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy Exclusion Criteria: * Pregnant or breastfeeding women * Participants who are out of locally approved indications, dosage, and administration including medication error * Contraindication in use by locally approved indications, dosage, and administration
References
Publications (0)
Data not yet available
No reference posted for this study.