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

Completed

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin
• Interventions: Drug: MabThera

• Registration Number: NCT03289182
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Primary Completion: 2020-10-27
• Study Completion: 2020-10-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MabThera	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events	Baseline up to Year 6

Secondary Outcome Measures

Name	Time	Method
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
Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL	Baseline up to Year 6

Trial Locations

Locations (25)

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon-si,, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Daegu Catholic University Medical Center; Hematology; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital; Department of Hematology; 🇰🇷 Gyeonggi-do, Korea, Republic of

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