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)

November 1, 2016 updated by: Genentech, Inc.

A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety, Efficacy and Pharmacokinetics 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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Kurralta Park, South Australia, Australia, 5037
    • Victoria
      • Coburg, VIC, Victoria, Australia, 3058
      • Fitzroy, Victoria, Australia, 3065
      • Frankston, Victoria, Australia, 3199
      • Parkville, Victoria, Australia, 3052
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
  • Brazil
    • ES
      • Cachoeiro de Itapemirim, ES, Brazil, 29308-014
    • MG
      • Belo Horizonte, MG, Brazil, 30150-270
      • Belo Horizonte, MG, Brazil, 30150-281
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20211-030
    • RS
      • Caxias do Sul, RS, Brazil, 95070-560
      • Porto Alegre, RS, Brazil, 90035-003
      • Porto Alegre, RS, Brazil, 90110-270
      • Porto Alegre, RS, Brazil, 90020-090
    • SP
      • Santo Andre, SP, Brazil, 09060-650
      • São Paulo, SP, Brazil, 01427-001
  • Czech Republic
      • Brno, Czech Republic, 625 00
      • Hradec Kralove, Czech Republic, 500 05
      • Prague 2, Czech Republic, 128 08
  • France
      • Lille, France, 59037
      • Pierre Benite, France, 69495
  • Israel
      • Afula, Israel, 18101
      • Petah Tikva, Israel, 4937211
      • Ramat Gan, Israel, 5262100
      • Rehovot, Israel, 76100
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
    • Liguria
      • Genova, Liguria, Italy, 16128
    • Lombardia
      • Cremona, Lombardia, Italy, 26100
      • Milano, Lombardia, Italy, 20133
      • Milano, Lombardia, Italy, 20162
      • Rozzano, Lombardia, Italy, 20089
    • Piemonte
      • Torino, Piemonte, Italy, 10128
  • Poland
      • Chorzow, Poland, 41-500
      • Gdansk, Poland, 80-952
      • Warszawa, Poland, 00-909
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • Russian Federation
      • Kazan, Russian Federation, 420029
      • Moscow, Russian Federation, 115478
      • Petrozavodsk, Russian Federation, 185019
      • Ryazan, Russian Federation, 390039
      • St. Petersburg, Russian Federation, 191024
  • Ukraine
      • Cherkassy, Ukraine, 18009
      • Dnipropetrovsk, Ukraine, 49102
      • Donetsk, Ukraine, 83045
      • Ivano-Frankivsk, Ukraine, 76018
      • Khmelnitskyy, Ukraine, 29000
      • Kyiv, Ukraine, 03150
      • Lviv, Ukraine, 79044
      • Poltava, Ukraine, 36024
      • Zhytomir, Ukraine, 10002
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
      • London, United Kingdom, EC1A 7BE
  • United States
    • California
      • Alhambra, California, United States, 91801
      • Antioch, California, United States, 94531
      • Berkeley, California, United States, 94704
      • Burbank, California, United States, 91505
      • Duarte, California, United States, 91010
      • Dublin, California, United States, 94568
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90073
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90024
      • Los Angeles, California, United States, 90095-1772
      • Northridge, California, United States, 91325
      • Pleasant Hill, California, United States, 94523
      • San Leandro, California, United States, 94578-2626
      • San Luis Obispo, California, United States, 93454
      • Santa Monica, California, United States, 90404
    • Colorado
      • Fort Collins, Colorado, United States, 80528
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
    • Florida
      • Bay Pines, Florida, United States, 33744
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Decatur, Illinois, United States, 62526
      • Harvey, Illinois, United States, 60426
      • Tinley Park, Illinois, United States, 60477
    • Louisiana
      • Shreverport, Louisiana, United States, 71103
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Bethesda, Maryland, United States, 20817
      • Bethesda, Maryland, United States, 20874
      • Randallstown, Maryland, United States, 21133
    • Michigan
      • Lansing, Michigan, United States, 48912
      • Lansing, Michigan, United States, 48909
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Henderson, Nevada, United States, 89052
      • Las Vegas, Nevada, United States, 89169
      • Las Vegas, Nevada, United States, 89148
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
    • New Mexico
      • Farmington, New Mexico, United States, 87401
    • New York
      • Oneida, New York, United States, 13421
      • Oswego, New York, United States, 13126
      • Syracuse, New York, United States, 13210
    • Ohio
      • Middletown, Ohio, United States, 45042
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
      • Pittsburgh, Pennsylvania, United States, 15224
    • Texas
      • Corpus Christi, Texas, United States, 78405
      • Lubbock, Texas, United States, 79410
      • Lubbock, Texas, United States, 79415
    • Washington
      • Everett, Washington, United States, 98201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
Drug: rituximab
Intravenous repeating dose
Experimental: B
Drug: rituximab
Intravenous repeating dose
Drug: ABT-263
Oral repeating dose
Experimental: C
Drug: rituximab
Intravenous repeating dose
Drug: ABT-263
Oral repeating dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival
Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])
From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: Approximately 40 months from FPI
Approximately 40 months from FPI
Duration of response
Time Frame: Approximately 40 months from FPI
Approximately 40 months from FPI
Complete response (CR) rate
Time Frame: Approximately 40 months from FPI
Approximately 40 months from FPI
Progression-free survival as assessed by a blinded, independent review
Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI)
From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI)
ORR as assessed by a blinded, independent review
Time Frame: Approximately 40 months from FPI
Approximately 40 months from FPI
Duration of response as assessed by a blinded, independent review
Time Frame: Approximately 40 months from FPI
Approximately 40 months from FPI
CR rate as assessed by a blinded, independent review
Time Frame: Approximately 40 months from FPI
Approximately 40 months from FPI
Overall survival (OS)
Time Frame: From randomization until death due to any cause (approximately 4 years after Last Patient In)
From randomization until death due to any cause (approximately 4 years after Last Patient In)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: William Ho, M.D., Ph.D., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABT4710n
  • 2009-012152-24 (EudraCT Number)
  • GP00763 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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