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

Roche

Status: Completed

Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: MabThera

Study type: Observational

Funder types: Industry

Identifiers

NCT03289182

ML39600

Details and patient eligibility

About

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.

Enrollment: 701 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

701 participants in 1 patient group

MabThera

Description:

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.

Treatment:

Drug: MabThera