A PHASE II, MULTICENTER, RANDOMIZED, CONTROLLED, OPEN-LABEL STUDY OF THE SAFETY, EFFICACY AND PHARMACOKINETICS OF ABT-263 IN COMBINATION WITH RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH B-CELL, CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

• Conditions: B-CELL, CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); MedDRA version: 13.1Level: LLTClassification code 10008956Term: Chronic lymphatic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-012152-24-GB
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Signed informed consent
• Age = 18 years
• Previously untreated, CD20-positive B-cell CLL, as defined above, and one or
more criteria that dictate the need for treatment
• ECOG performance status of 0 or 1; patients with an ECOG performance status of 2 due solely to their CLL disease are also eligible to be enrolled
• Life expectancy > 6 months
• Willingness and capability to be accessible for follow-up until study termination
or death
• For patients of reproductive potential (both males and females), use of a
reliable means of contraception
• Laboratory values within limits specified in the protocol
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prolymphocytic leukemia
• Richter’s transformation to an aggressive B-cell malignancy (e.g., DLBCL)
• Prior radiotherapy to a lesion(s) that will be used to assess response
• Patients with a history of other malignancies within 2 years prior to study entry except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade, localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy alone with curative intent
• Prior treatment with rituximab, ABT-263 or other pro-apoptotic agents (e.g. Bcl-2 inhibitors)
• Current or recent (within the 28 days prior to initiation of study treatment) participation in another experimental drug study
• Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months prior to initiation of study treatment
• Patients receiving therapeutic anticoagulation with heparin or warfarin or patients receiving any drugs or herbal supplements that are known to inhibit platelet function (including low-dose aspirin) within 7 days of the first dose of ABT-263. Note: patients receiving low-dose anticoagulation for the purpose of maintaining central venous catheter patency are eligible.
• Known human immunodeficiency virus (HIV) infection, seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA.
• Hisotry of anaphylaxis, allergic reaction or hypersensitivity to sulfites (sodium metabisulphite is included in study drug formulation).
• Any contraindicationto alcohol ingestion (study drug formulation includes approximately 15% ethanol).

Study & Design

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