Clinical trial · Observational
Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting
A NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND NURSE MANAGEMENT DURING INDUCTION TREATMENT WITH MABTHERA S.C. FOLLOWING A FIRST INITIAL MABTHERA I.V. TREATMENT, IN PATIENTS WITH NON-HODGKINS LYMPHOMA IN A REAL-LIFE SETTING
- 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, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (1)
- measure
- Response rate using the International Working Group criteria
- timeFrame
- 8 months
Secondary outcomes (3)
- measure
- Incidence of adverse events
- timeFrame
- Through to end of study, up to approximately 1 year
- measure
- Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV
- timeFrame
- Through to end of study, up to approximately 1 year
- measure
- Incidence of serious adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation: * As treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy * As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with chemotherapy 2. At least 4 treatment cycles with MabThera is planned 3. Patients \>/= 18 years at inclusion 4. Patients written informed consent 5. Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study Exclusion Criteria: 1. Contraindications according to SPC for MabThera SC formulation: * Hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients * Active and severe infections * Patients with severe immunsuppression 2. Patient included in clinical trials with experimental pharmaceuticals 3. Pregnancy
References
Publications (0)
Data not yet available