Status:
COMPLETED
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
19+ years
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 expect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2020
Estimated Enrollment :
701 Patients enrolled
Trial Details
Trial ID
NCT03289182
Start Date
September 15 2017
End Date
October 27 2020
Last Update
January 11 2021
Active Locations (25)
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1
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea, 420-767
2
Inje University Busan Paik Hospital
Busan, South Korea, 47392
3
Pusan National University Hospital
Busan, South Korea, 49241
4
Keimyung University Dongsan Medical Center
Daegu, South Korea, 41931