Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Astellas

Status: Completed

Conditions: Lymphoma, Non-Hodgkin

Treatments: Other: Ribomustin; Other: rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02072967

RU-BEN-NI-001

Details and patient eligibility

About

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
• Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee
• Eastern Cooperative Oncology Group (ECOG) status < 2.
• Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment
• Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy

Exclusion criteria

• Indolent Non-Hodgkin's Lymphoma transformation
• Lymphoma with central nervous system (CNS) involvement
• Presence of second malignant tumor.
• Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
• Contraindications for Ribomustin usage in accordance with product label
• Contradictions for rituximab usage in accordance with product label

Trial design

97 participants in 1 patient group

Ribomustin and rituximab

Treatment:

Other: rituximab

Other: Ribomustin