Clinical trial NCT03289182: An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
Official title: Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 701
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: Baseline up to Year 6
Secondary outcomes:
measure: Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL
timeFrame: Baseline up to Year 6
measure: Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
timeFrame: Baseline up to Year 6
Other outcomes:
Locations:
city: Bucheon-si,
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center; Hematology
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital; Department of Hematology
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University, Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital; Department of Oncology
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System; Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Division of Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital; Surgery
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital; Department of Hematology & Oncology
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
Study officials:
References: