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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01087151
First received: March 11, 2010
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: ABT-263
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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]) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]
  • Complete response (CR) rate [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • ORR as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]
  • Duration of response as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]
  • CR rate as assessed by a blinded, independent review [ Time Frame: Approximately 40 months from FPI ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From randomization until death due to any cause (approximately 4 years after Last Patient In) ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: rituximab
Intravenous repeating dose
Experimental: B Drug: ABT-263
Oral repeating dose
Drug: rituximab
Intravenous repeating dose
Experimental: C Drug: ABT-263
Oral repeating dose
Drug: rituximab
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087151

  Show 103 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: William Ho, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01087151     History of Changes
Other Study ID Numbers: ABT4710n, 2009-012152-24, GP00763
Study First Received: March 11, 2010
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Rituxan
Apoptosis
BCl-2

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014