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A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT02966756
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : April 21, 2021
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 April 21, 2021
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date May 31, 2024   (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
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
  • Complete Response Rate (CRR) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified iwCLL NCI-WG criteria.
  • Duration of Overall Response (DOR) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]
    DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or 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.
  • 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 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
  • 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.
  • Percentage 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. ]
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 Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official Title  ICMJE A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Brief Summary This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed were intolerant to or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
Intervention  ICMJE Drug: Venetoclax
Tablet; Oral
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta
Study Arms  ICMJE
  • Experimental: Cohort 1: Venetoclax
    Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).
    Intervention: Drug: Venetoclax
  • Experimental: Cohort 2: Venetoclax
    Participants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, were intolerant to, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).
    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: April 19, 2021)
110
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
70
Estimated Study Completion Date  ICMJE September 28, 2026
Estimated Primary Completion Date May 31, 2024   (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)/SLL 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.
    • CLL 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).
    • SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate.
    • Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy.
  • Participant must have 17p deletion, assessed by a central laboratory.
  • Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.
  • Participants (in Cohort 2) must meet both of the following:

    • Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment;
    • And either of the following: (a) relapsed/refractory disease to chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having 17p deletion, or Cumulative Illness Rating Scale (CIRS) >6 or calculated creatinine clearance <70 mL/min.
  • 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.
  • No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

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 for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:

    • Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents.
    • 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 844-663-3742 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
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)
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 March 2021

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