Clinical trial NCT02199288: Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-07-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients within label indication for MabThera SC and subject for induction therapy with MabThera SC; patients object for maintenance therapy are excluded

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate using the International Working Group criteria
timeFrame: 8 months
Secondary outcomes:
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: Through to end of study, up to approximately 1 year
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
city: Halmstad
country: Sweden
city: Helsingborg
country: Sweden
city: Linkoeping
country: Sweden
city: Luleå
country: Sweden
city: Visby
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: