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

NCT ID: NCT02199288

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Eskilstuna, , Sweden

Site Status

Halmstad, , Sweden

Site Status

Helsingborg, , Sweden

Site Status

Linköping, , Sweden

Site Status

Luleå, , Sweden

Site Status

Örebro, , Sweden

Site Status

Visby, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ML29314

Identifier Type: -

Identifier Source: org_study_id