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A Study of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia in the Presence of 17p Deletion

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ClinicalTrials.gov Identifier: NCT02966756
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE November 15, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date August 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
Overall Response Rate (ORR) [ Time Frame: Measured up to 2 years after the last participant has enrolled in the study. ]
ORR is the proportion of participants with an overall response (complete remission [CR], plus complete remission with incomplete bone marrow recovery [CRi], plus nodular partial remission [nPR], plus partial remission [PR]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02966756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • Partial Remission (PR) rate [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    PR rate is defined as the proportion of subjects who achieved nPR or PR per the NCI-WG criteria (determined by the IRC).
  • Event Free Survival (EFS) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
  • Percent of participants who move on to stem cell transplant [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
  • Overall Survival (OS) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]
    OS is defined as number of days from the date of first dose to the date of death.
  • Progression Free Survival (PFS) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]
    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
  • Time to Progression (TTP) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]
    TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).
  • Time to 50% reduction in absolute lymphocyte count (ALC) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    Time to 50% reduction in ALC is defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC has reduced to 50% of the baseline value
  • Complete Remission (CR) rate [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    CR rate is defined as the proportion of participants who achieved a CR or CRi per the NCI-WG criteria (determined by the IRC).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • Complete Response (CR) rate [ Time Frame: Up to Week 36 ]
    CR rate is defined as the proportion of participants who achieved a CR or CRi per the NCI-WG criteria (determined by the IRC).
  • Partial Response (PR) rate [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    PR rate is defined as the proportion of subjects who achieved nPR or PR per the NCI-WG criteria (determined by the IRC).
  • Progression Free Survival (PFS) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
  • Event Free Survival (EFS) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
  • Time to Progression (TTP) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).
  • Time to 50% reduction in absolute lymphocyte count (ALC) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    Time to 50% reduction in ALC is defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC has reduced to 50% of the baseline value
  • Overall Survival (OS) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    OS is defined as number of days from the date of first dose to the date of death.
  • Percent of participants who move on to stem cell transplant [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia in the Presence of 17p Deletion
Official Title  ICMJE A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia in the Presence of 17p Deletion
Brief Summary This is a Phase 2, open-label, single-arm, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in the presence of 17p deletion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia (CLL)
Intervention  ICMJE Drug: Venetoclax
tablet
Other Names:
  • ABT-199
  • GDC-0199
Study Arms  ICMJE Experimental: Venetoclax
Venetoclax will be administered orally starting with 20 mg once daily (QD); dose escalation will proceed weekly in the following progression: 50 mg QD, 100 mg QD, 200 mg QD, 400 mg QD, as tolerated.
Intervention: Drug: Venetoclax
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 29, 2025
Estimated Primary Completion Date August 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) NCI-WG Guidelines and the following:
  • Participant must have an indication for treatment according to the 2008 Modified IWCLL National Cancer Institute-Working Group (NCI-WG) Guidelines;
  • Participant must have measurable disease (B-lymphocytosis greater than 5 × 10^9/L or an enlarged lymph node(s) (LDi > 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL);
  • Participant must have relapsed or refractory CLL after receiving at least one prior line of therapy
  • Relapsed - must have completed at least 2 cycles of one prior line of therapy;
  • Refractory - must have progressed after at least 1 cycle of one prior line of therapy;
  • Participant must have 17p deletion, assessed by a central laboratory
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  • Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening

Exclusion Criteria:

  • Participant has undergone an allogeneic stem cell transplant.
  • Participant has developed Richter's transformation confirmed by biopsy.
  • Participant has prolymphocytic leukemia.
  • Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
  • Participant has previously received venetoclax.
  • Participant is known to be positive for Human Immunodeficiency Virus (HIV).
  • Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
  • Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to less than Common Toxicity Criteria (CTC) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:

    • Any anti-cancer therapy including chemotherapy, or radiotherapy;
    • Investigational therapy, including targeted small molecule agents.
  • Participant has known allergy to both xanthine oxidase inhibitors and rasburicase
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: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   China,   New Zealand,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02966756
Other Study ID Numbers  ICMJE M14-728
2017-002413-54 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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 Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date November 2019

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