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Trial record 1 of 1 for:    NCT01087151
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087151
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE March 11, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE August 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
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]) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
  • Overall response rate (ORR) [ Time Frame: Approximately 40 months from FPI ]
  • Duration of response [ Time Frame: Approximately 40 months from FPI ]
  • Complete response (CR) rate [ Time Frame: 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) ]
  • ORR as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ]
  • Duration of response as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ]
  • CR rate as assessed by a blinded, independent review [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: ABT-263
    Oral repeating dose
  • Drug: rituximab
    Intravenous repeating dose
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: rituximab
  • Experimental: B
    Interventions:
    • Drug: ABT-263
    • Drug: rituximab
  • Experimental: C
    Interventions:
    • Drug: ABT-263
    • Drug: rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2013)
118
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2010)
120
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Czech Republic,   France,   Israel,   Italy,   Poland,   Puerto Rico,   Russian Federation,   Ukraine,   United Kingdom,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT01087151
Other Study ID Numbers  ICMJE ABT4710n
2009-012152-24 ( EudraCT Number )
GP00763 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE AbbVie (prior sponsor, Abbott)
Investigators  ICMJE
Study Director: William Ho, M.D., Ph.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP