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

Cancer
Leukemia
Non Hodgkin Lymphoma (NHL)
Lymphoma

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase N/A

Trial Identifier NCT03289182, ML39600

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

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

Study 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

Gender

All

Age

≥ 19 Years

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

For the latest version of this information please go to www.forpatients.roche.com

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com