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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03289182

Enrollment

701

Registered

2017-09-20

Start date

2017-09-15

Completion date

2020-10-27

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell

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.

Interventions

DRUGMabThera

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Adverse Events	Baseline up to Year 6

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026