Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskilstuna, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
At least 4 treatment cycles with MabThera is planned
Patients >/= 18 years at inclusion
Patients written informed consent
Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study

Exclusion criteria

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
Patient included in clinical trials with experimental pharmaceuticals
Pregnancy

Treatment and study plan

Primary outcomes

Response rate using the International Working Group criteria

Time frame: 8 months

Secondary outcomes

Incidence of adverse events

Time frame: 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

Time frame: Through to end of study, up to approximately 1 year
Incidence of serious adverse events

Time frame: Through to end of study, up to approximately 1 year

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 24, 2014
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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