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

NCT03289182

CompletedN/A

Sponsor: Hoffmann-La Roche

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

Interventions: MabThera

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (25)

Bucheon-si, South Korea
Busan, South Korea
Busan, South Korea
Daegu, South Korea
Daegu, South Korea
Daegu, South Korea
Daejeon, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeongsangnam-do, South Korea
Incheon, South Korea
Jeollanam-do, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Ulsan, South Korea