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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02199288

Enrollment

Registered

2014-07-24

Start date

2014-08-31

Completion date

2016-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate using the International Working Group criteria	8 months

Secondary

Measure	Time frame
Incidence of adverse events	Through to end of study, up to approximately 1 year
Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV	Through to end of study, up to approximately 1 year
Incidence of serious adverse events	Through to end of study, up to approximately 1 year

Countries

Sweden

Outcome results