An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
1 other identifier
observational
701
1 country
25
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 expected to be 6 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2017
CompletedFirst Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2020
CompletedJanuary 11, 2021
January 1, 2021
3.1 years
September 18, 2017
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Adverse Events
Baseline up to Year 6
Secondary Outcomes (2)
Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL
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
Baseline up to Year 6
Study Arms (1)
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.
Interventions
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
Participants receiving treatment for NHL or CLL with MabThera SC under observation according to standard of care and in line with the current local labelling in Korea.
You may qualify if:
- Participants administered with MabThera subcutaneously within the approved indication in Korea
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center; Hematology
Daegu, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Hallym University Sacred Heart Hospital; Department of Hematology
Gyeonggi-do, 431-070, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Inje University, Sanggye-Paik Hospital
Seoul, 01757, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Seoul National University Hospital; Department of Oncology
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University Health System; Oncology
Seoul, 120-752, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
Seoul, 137-701, South Korea
Korea Cancer Center Hospital; Surgery
Seoul, 139-709, South Korea
Korea University Guro Hospital; Department of Hematology & Oncology
Seoul, 152-703, South Korea
SMG-SNU Boramae Medical Center
Seoul, 156-707, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 20, 2017
Study Start
September 15, 2017
Primary Completion
October 27, 2020
Study Completion
October 27, 2020
Last Updated
January 11, 2021
Record last verified: 2021-01