A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)

Genentech

Status and phase

Completed

Phase 2

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: rituximab

Drug: ABT-263

Study type

Interventional

Funder types

Industry

Identifiers

NCT01087151

GP00763 (Other Identifier)

ABT4710n

2009-012152-24 (EudraCT Number)

Details and patient eligibility

About

This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.

Enrollment

118 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Previously untreated, CD20-positive B-cell CLL
ECOG performance status of 0 or 1
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

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 unless that lesion(s) shows clear evidence of progression at baseline
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
Current or recent (within the 28 days prior to initiation of study treatment) participation in another experimental drug study
Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to treatment onset or anticipation of the need for major surgery during the course of the study
Active infection requiring parenteral antibiotics or antiviral or antifungal agents at the onset of study treatment
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.
Patients who have an inherited or acquired bleeding diathesis, including (but not limited to) hemophilia or immune or thrombotic thrombocytopenic purpura, or who have had an underlying condition that predisposes to abnormal bleeding (e.g., peptic ulcer disease) within 1 year prior to the first dose of ABT-263
Patients with a history of refractoriness to platelet transfusions
Clinically significant cardiovascular disease
Known human immunodeficiency virus (HIV) infection, seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA
Pregnancy or breastfeeding
Concurrent (or within 7 days prior to the first dose of study treatment) systemic corticosteroid therapy except some low-dose corticosteroid therapies
History of other disease, metabolic dysfunction, physical or laboratory finding(s) giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, might affect interpretation of the results of the study or render the patient at high risk from treatment complications
History of anaphylaxis, allergic reaction, or hypersensitivity to sulfites (sodium metabisulphite is included in study drug formulation)
Any contraindication to alcohol ingestion (study drug formulation includes approximately 15% ethanol)