An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)

Hoffmann-La Roche701 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

701

Conditions

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

Interventions

MabTheraDRUG

Participants will be administered MabThera 1400 mg (NHL) or 1600 mg (CLL) at the discretion of the physician in accordance with local clinical practice and local labeling.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (25)

Soon Chun Hyang University Hospital Bucheon

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 Cheson 2014 Criteria for NHL

Time frame: Baseline up to Year 6

Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria

Time frame: Baseline up to Year 6

Data from ClinicalTrials.gov

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