A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199) PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB

• Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL); MedDRA version: 16.1Level: LLTClassification code 10068852Term: B-cell chronic lymphocytic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002110-12-FR
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-20
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2008).
Patients must have peripheral blood B-lymphocyte counts which clonally express CD5, CD19/20 and CD23 and are either kappa or lambda light-chain restricted.
Pro-lymphocytes may comprise no more than 55% of total circulating lymphocytes.
At initial diagnosis of CLL (ie, prior to front-line treatment), the peripheral lymphocyte count must have been >5000/mm3. Patients must meet the following criteria for relapsed or refractory CLL (per the iwCLL guidelines [Hallek et al. 2008]):
-Relapsed disease: a patient who previously achieved a CR or PR, but after a period of 6 months or more demonstrates evidence of progression;
-refractory disease: treatment failure or disease progression within 6 months of the last anti-leukemia therapy.
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 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 185

Exclusion Criteria

Transformation of CLL to aggressive NHL (eg, Richter's transformation, prolymphocytic leukemia, or DLBCL) or CNS involvement by CLL.

Study & Design

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