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Clinical Trials/NCT02199288
NCT02199288
Completed
N/A

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

Hoffmann-La Roche0 sites54 target enrollmentAugust 2014
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ConditionsNon-Hodgkin's Lymphoma

Overview

Phase
N/A
Intervention
Not specified
Conditions
Non-Hodgkin's Lymphoma
Sponsor
Hoffmann-La Roche
Enrollment
54
Primary Endpoint
Response rate using the International Working Group criteria
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
July 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Response rate using the International Working Group criteria

Time Frame: 8 months

Secondary Outcomes

  • 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)

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