CLL11: A Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Phase 1

• Conditions: Patients with previously untreated B-CLL with comorbidities.; MedDRA version: 19.0 Level: LLT Classification code 10003946 Term: B-Lymphocytic, CLL (Kiel Classification) System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-012476-28-GB
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-11
• Study Completion: 2017-08-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 781

Inclusion Criteria

1. Adult patients, aged 18 years or older
2. Have documented CD20+ B-CLL
3. Previously untreated CLL requiring treatment according to the NCI criteria (Hallek,M; Blood 2008)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 262
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 524

Exclusion Criteria

1. Prior CLL therapy
2. Transformation of CLL to aggressive NHL (Richter’s transformation)
3. History of other malignancy unless the malignancy has been in remission without treatment for = 2 years prior to enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified