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)
NCT ID: NCT01087151
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2010-08-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
rituximab
Intravenous repeating dose
B
ABT-263
Oral repeating dose
rituximab
Intravenous repeating dose
C
ABT-263
Oral repeating dose
rituximab
Intravenous repeating dose
Interventions
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ABT-263
Oral repeating dose
rituximab
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Ho, M.D., Ph.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Alhambra, California, United States
Antioch, California, United States
Berkeley, California, United States
Burbank, California, United States
Duarte, California, United States
Dublin, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Pleasant Hill, California, United States
San Leandro, California, United States
San Luis Obispo, California, United States
Santa Monica, California, United States
Fort Collins, Colorado, United States
Norwalk, Connecticut, United States
Bay Pines, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Harvey, Illinois, United States
Tinley Park, Illinois, United States
Shreverport, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Bethesda, Maryland, United States
Randallstown, Maryland, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Cherry Hill, New Jersey, United States
Farmington, New Mexico, United States
Oneida, New York, United States
Oswego, New York, United States
Syracuse, New York, United States
Middletown, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Corpus Christi, Texas, United States
Lubbock, Texas, United States
Lubbock, Texas, United States
Everett, Washington, United States
Randwick, New South Wales, Australia
Greenslopes, Queensland, Australia
Adelaide, South Australia, Australia
Kurralta Park, South Australia, Australia
Coburg, VIC, Victoria, Australia
Fitzroy, Victoria, Australia
Frankston, Victoria, Australia
Parkville, Victoria, Australia
Fremantle, Western Australia, Australia
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Caxias do Sul, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Brno, , Czechia
Hradec Králové, , Czechia
Prague, , Czechia
Lille, , France
Pierre-Bénite, , France
Afula, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Modena, Emilia-Romagna, Italy
Genoa, Liguria, Italy
Cremona, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Rozzano, Lombardy, Italy
Turin, Piedmont, Italy
Chorzów, , Poland
Gdansk, , Poland
Warsaw, , Poland
San Juan, , Puerto Rico
Kazan', , Russia
Moscow, , Russia
Petrozavodsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Cherkassy, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Khmelnitskyy, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Poltava, , Ukraine
Zhytomyr, , Ukraine
Leicester, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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2009-012152-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GP00763
Identifier Type: OTHER
Identifier Source: secondary_id
ABT4710n
Identifier Type: -
Identifier Source: org_study_id