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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT03289182

Collaborator

(none)

701

Enrollment

Locations

37.4

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell	Drug: MabThera

Study Design

Study Type:

Observational

Actual Enrollment :

701 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Actual Study Start Date :

Sep 15, 2017

Actual Primary Completion Date :

Oct 27, 2020

Actual Study Completion Date :

Oct 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: 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.

Arm

Intervention/Treatment

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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Adverse Events [Baseline up to Year 6]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Soon Chun Hyang University Hospital Bucheon	Bucheon-si,	Korea, Republic of	420-767
2	Inje University Busan Paik Hospital	Busan	Korea, Republic of	47392
3	Pusan National University Hospital	Busan	Korea, Republic of	49241
4	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of	41931
5	Yeungnam University Medical Center	Daegu	Korea, Republic of	42415
6	Daegu Catholic University Medical Center; Hematology	Daegu	Korea, Republic of
7	Chungnam National University Hospital	Daejeon	Korea, Republic of	35015
8	Korea University Ansan Hospital	Gyeonggi-do	Korea, Republic of	15355
9	St. Vincent's Hospital	Gyeonggi-do	Korea, Republic of	16247
10	Hallym University Sacred Heart Hospital; Department of Hematology	Gyeonggi-do	Korea, Republic of	431-070
11	Pusan National University Yangsan Hospital	Gyeongsangnam-do	Korea, Republic of	50612
12	Gachon University Gil Medical Center	Incheon	Korea, Republic of	21565
13	Chonnam National University Hwasun Hospital	Jeollanam-do	Korea, Republic of	58128
14	Inje University, Sanggye-Paik Hospital	Seoul	Korea, Republic of	01757
15	Korea University Anam Hospital	Seoul	Korea, Republic of	02841
16	Kangbuk Samsung Hospital	Seoul	Korea, Republic of	03181
17	Ewha Womans University Mokdong Hospital	Seoul	Korea, Republic of	07985
18	Seoul National University Hospital; Department of Oncology	Seoul	Korea, Republic of	110-744
19	Severance Hospital, Yonsei University Health System; Oncology	Seoul	Korea, Republic of	120-752
20	Samsung Medical Centre; Division of Hematology/Oncology	Seoul	Korea, Republic of	135-710
21	St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine	Seoul	Korea, Republic of	137-701
22	Korea Cancer Center Hospital; Surgery	Seoul	Korea, Republic of	139-709
23	Korea University Guro Hospital; Department of Hematology & Oncology	Seoul	Korea, Republic of	152-703
24	SMG-SNU Boramae Medical Center	Seoul	Korea, Republic of	156-707
25	Ulsan University Hosiptal	Ulsan	Korea, Republic of	44033