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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • 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

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
Intervention / Treatment
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

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

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

Genentech, Inc.

Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

  • 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

August 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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