An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT03289182
Last Updated: 2021-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
701 participants
OBSERVATIONAL
2017-09-15
2020-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
MabThera
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.
Interventions
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MabThera
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 Criteria
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Inclusion Criteria
* Participants previously untreated with MabThera subcutaneously
* 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
\- Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy
Exclusion Criteria
* Participants who are out of locally approved indications, dosage, and administration including medication error
* Contraindication in use by locally approved indications, dosage, and administration
19 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Daegu Catholic University Medical Center; Hematology
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
St. Vincent's Hospital
Gyeonggi-do, , South Korea
Hallym University Sacred Heart Hospital; Department of Hematology
Gyeonggi-do, , South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Inje University, Sanggye-Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Seoul National University Hospital; Department of Oncology
Seoul, , South Korea
Severance Hospital, Yonsei University Health System; Oncology
Seoul, , South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, , South Korea
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
Seoul, , South Korea
Korea Cancer Center Hospital; Surgery
Seoul, , South Korea
Korea University Guro Hospital; Department of Hematology & Oncology
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Countries
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Other Identifiers
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ML39600
Identifier Type: -
Identifier Source: org_study_id
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