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

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.

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Key information

Conditions

Lymphoma, Non-Hodgkin Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mabthera

Drug

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.

Primary outcomes

Percentage of Participants with Adverse Events

Time frame: Baseline up to Year 6

Secondary outcomes

Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL

Time frame: 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

Time frame: Baseline up to Year 6

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Sep 20, 2017
Registry last updated: Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed