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A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

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ClinicalTrials.gov Identifier: NCT02141282
Recruitment Status : Active, not recruiting
First Posted : May 19, 2014
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: ABT-199 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Actual Study Start Date : September 10, 2014
Estimated Primary Completion Date : November 8, 2018
Estimated Study Completion Date : December 8, 2021


Arm Intervention/treatment
Experimental: ABT-199 after ibrutinib therapy
Single daily doses increasing weekly as tolerated
Drug: ABT-199
ABT-199 monotherapy

Experimental: ABT-199 after ibrutinib or idelalisib therapy
Single daily doses increasing weekly as tolerated
Drug: ABT-199
ABT-199 monotherapy

Experimental: ABT-199 after idelalisib therapy
Single daily doses increasing weekly as tolerated
Drug: ABT-199
ABT-199 monotherapy




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    To evaluate the efficacy of ABT-199 monotherapy in subjects with chronic lymphocytic leukemia (CLL) relapsed or refractory to B-cell Receptor Signaling Pathway Inhibitors. Assessed by the investigator, based on laboratory results, physical examinations, CT scans, and bone marrow examinations


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    The number of days from the date of first response (complete response (CR) or partial response (PR)) to the earliest recurrence or disease progression (PD)

  2. Time to progression (TTP) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    The number of days from the date of first dose or enrollment if not dosed to the date of earliest PD

  3. Overall survival (OS) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    The number of days from the date of first dose to the date of death for all dosed subjects

  4. Progression-free survival (PFS) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    The number of days from the date of first dose to the date of earliest PD or death


Other Outcome Measures:
  1. Time to Next Anti-CLL Treatment (TNT) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    The number of days from the date of first dose of ABT-199 to the date of first dose of new non-protocol anti-leukemia therapy (NPT) or death from any cause

  2. Rate of minimal residual disease (MRD) negativity status [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    The presence of less that once CLL cell per 10,000 leukocytes in either peripheral blood and/or bone marrow



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have a diagnosis of CLL that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) criteria
  • Subject has relapsed/refractory disease with an indication for treatment
  • Subject has refractory disease or developed recurrence after therapy with a BCR PI
  • Subject must have an Eastern Cooperative Oncology Group performance score of equal to or less than 2
  • Subject must have adequate bone marrow function at Screening
  • Subject must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening

Exclusion Criteria:

  • Subject has undergone an allogeneic stem cell transplant within the past year
  • Subject has developed Richter's transformation confirmed by biopsy
  • Subject has active and uncontrolled autoimmune cytopenia
  • Subject has malabsorption syndrome or other condition that precludes enteral route of administration
  • Subject is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment
  • Subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141282


Locations
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United States, California
Ucsd /Id# 128535
La Jolla, California, United States, 92037
University of California, Los Angeles /ID# 127262
Los Angeles, California, United States, 90095
Stanford Univ School of Med /ID# 126495
Stanford, California, United States, 94305-2200
United States, District of Columbia
Medstar Georgetown Univ Med Ct /ID# 127261
Washington, District of Columbia, United States, 20007
United States, Georgia
Emory University Hospital /ID# 131249
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University /ID# 126497
Chicago, Illinois, United States, 60611-2927
United States, Massachusetts
Beth Israel Deaconess Med Ctr /ID# 134509
Boston, Massachusetts, United States, 02215-5400
Dana-Farber Cancer Institute /ID# 126496
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic - Rochester /ID# 130013
Rochester, Minnesota, United States, 55905-0001
United States, New York
Columbia Univ Medical Center /ID# 128536
New York, New York, United States, 10032-3725
New York Presbyterian Hospital - Weill Cornell Medical Center /ID# 129648
New York, New York, United States, 10032-3725
Univ Rochester Med Ctr /ID# 130011
Rochester, New York, United States, 14642
United States, Ohio
The Ohio State University - Columbus /ID# 127263
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania /ID# 126860
Philadelphia, Pennsylvania, United States, 19104-5502
United States, Texas
Univ TX, MD Anderson /ID# 126498
Houston, Texas, United States, 77030
United States, Utah
University of Utah /ID# 129984
Salt Lake City, Utah, United States, 84112-5500
University of Utah /ID# 130813
Salt Lake City, Utah, United States, 84112-5500
Sponsors and Collaborators
AbbVie
Roche-Genentech
Investigators
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Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02141282     History of Changes
Other Study ID Numbers: M14-032
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Oncology
Chronic Lymphocytic Leukemia
Cancer of the blood and bone marrow

Additional relevant MeSH terms:
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Idelalisib
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Receptors, Antigen, B-Cell
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs