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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199288
• Other study ID #: ML29314
• Status: Completed
• Phase: N/A
• First received: July 18, 2014
• Last updated: November 1, 2016
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate using the International Working Group criteria		8 months	No
Secondary	Incidence of adverse events		Through to end of study, up to approximately 1 year	No
Secondary	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	No
Secondary	Incidence of serious adverse events		Through to end of study, up to approximately 1 year	No