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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 : June 3, 2019
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 19, 2014
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE September 10, 2014
Estimated Primary Completion Date November 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02141282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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)
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: May 15, 2014)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: ABT-199
ABT-199 monotherapy
Study Arms  ICMJE
  • Experimental: ABT-199 after ibrutinib therapy
    Single daily doses increasing weekly as tolerated
    Intervention: Drug: ABT-199
  • Experimental: ABT-199 after ibrutinib or idelalisib therapy
    Single daily doses increasing weekly as tolerated
    Intervention: Drug: ABT-199
  • Experimental: ABT-199 after idelalisib therapy
    Single daily doses increasing weekly as tolerated
    Intervention: Drug: ABT-199
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 19, 2018)
127
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2014)
40
Estimated Study Completion Date  ICMJE December 8, 2021
Estimated Primary Completion Date November 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02141282
Other Study ID Numbers  ICMJE M14-032
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Roche-Genentech
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2019

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