Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Hoffmann-La Roche25 sites in 1 country701 target enrollmentSeptember 15, 2017

ConditionsLymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell

InterventionsMabThera

DrugsMabThera

Overview

Phase: Not Applicable
Intervention: MabThera
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Hoffmann-La Roche
Enrollment: 701
Locations: 25
Primary Endpoint: Percentage of Participants with Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.

Registry

clinicaltrials.gov

Start Date

September 15, 2017

End Date

October 27, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants administered with MabThera subcutaneously within the approved indication in Korea
•Participants previously untreated with MabThera subcutaneously
•Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:
•Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
•Previously untreated FL participants in combination with chemotherapy
•Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
•Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy
•Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:
•Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy

Exclusion Criteria

•Pregnant or breastfeeding women
•Participants who are out of locally approved indications, dosage, and administration including medication error
•Contraindication in use by locally approved indications, dosage, and administration

Arms & Interventions

MabThera

Participants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years.

Intervention: MabThera

Outcomes

Primary Outcomes

Percentage of Participants with Adverse Events

Time Frame: Baseline up to Year 6

Secondary Outcomes

Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria(Baseline up to Year 6)
Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL(Baseline up to Year 6)