Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia (NORMA)

Astellas

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Treatments: Other: rituximab; Other: bendamustine

Study type: Observational

Funder types: Industry

Identifiers

NCT02110394

RU-BEN-NI-003

Details and patient eligibility

About

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin
• Informed Consent Form for personal data handling signed by the program participant

Exclusion criteria

• Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL
• 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

Trial design

190 participants in 1 patient group

bendamustine and rituximab

Treatment:

Other: bendamustine

Other: rituximab