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Study Evaluating Venetoclax in Subjects With Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02265731
Recruitment Status : Active, not recruiting
First Posted : October 16, 2014
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE October 16, 2014
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE September 22, 2014
Estimated Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Number of participants having treatment-emergent adverse events [ Time Frame: Approximately 2 years ]
    Collect all adverse events at each visit
  • Time to maximum plasma concentration (Tmax) of venetoclax [ Time Frame: Approximately 8 days ]
  • Maximum plasma concentration (Cmax) of venetoclax [ Time Frame: Approximately 8 days ]
  • Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax [ Time Frame: Approximately 8 days ]
  • Objective Response Rate (Phase 2) [ Time Frame: Approximately 48 months ]
    The proportion of participants with response (e.g., partial, complete response) using IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • Number of participants having treatment-emergent adverse events [ Time Frame: Approximately 2 years ]
    Collect all adverse events at each visit
  • Maximum plasma concentration (Cmax) of ABT-199 [ Time Frame: Approximately 8 days ]
  • Trough concentration (Ctrough) of ABT-199 [ Time Frame: Approximately 8 days ]
  • Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of ABT-199 [ Time Frame: Approximately 8 days ]
  • Time to maximum plasma concentration (Tmax) of ABT-199 [ Time Frame: Approximately 8 days ]
Change History Complete list of historical versions of study NCT02265731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Objective Response Rate (Phase 1) [ Time Frame: Approximately 48 months ]
    The proportion of participants with response (e.g., partial, complete response) using IWG (International Working Group) response criteria for NHL participants, IMWG (International Myeloma Working Group) response criteria for multiple myeloma participants, IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants or IWG (International Working Group) criteria for AML participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
  • Minimal Residual Disease (MRD) [ Time Frame: Approximately 2 years ]
  • Duration of Response [ Time Frame: Approximately 48 months ]
    Duration of response is defined as the number of days from the participant's initial response (e.g., partial, complete response per disease-appropriate response criteria) to the day that disease progression is objectively documented.
  • Time to disease progression [ Time Frame: Approximately 48 months ]
    Time to disease progression is defined as the number of days from the date the subject started the study drug to the date of the subject's progression (all events of progression will be included).
  • complete response or remission (CR) rate [ Time Frame: Approximately 48 months ]
    CR rate will be defined as the proportion of participants who achieved a complete response or remission (CR) or complete response with incomplete bone marrow recovery or complete remission with incomplete count recovery (CRi) per the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.
  • Partial response or remission (PR) rate [ Time Frame: Approximately 48 months ]
    PR rate will be defined as the proportion of subjects who achieved a nodular PR (nPR) or PR per the 2008 IWCLL criteria.
  • Progression Free Survival (PFS) [ Time Frame: Approximately 48 months ]
    Duration of progression-free survival (PFS) will be defined as the number of days from the date of first dose to the date of earliest disease progression or death.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • Objective Response Rate [ Time Frame: Approximately 48 months ]
    The proportion of participants with response (e.g., partial, complete response) using IWG (International Working Group) response criteria for NHL participants or IMWG (International Myeloma Working Group) response criteria for multiple myeloma participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
  • Duration of Response [ Time Frame: Approximately 48 months ]
    Duration of response is defined as the number of days from the participant's initial response (e.g., partial, complete response per disease-appropriate response criteria) to the day that disease progression is objectively documented.
  • Minimal Residual Disease (MRD) [ Time Frame: Approximately 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Venetoclax in Subjects With Hematological Malignancies
Official Title  ICMJE A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
Brief Summary This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Hodgkin Lymphoma (NHL)
  • Multiple Myeloma (MM)
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • Acute Myeloid Leukemia (AML)
Intervention  ICMJE
  • Drug: azacitadine
    75 mg/m2 by IV infusion or subcutaneous dosing
  • Drug: venetoclax
    Step-up doses of venetoclax to the designated cohort dose
  • Drug: rituximab / IDEC-C2B8
    375 mg/m2 on Week 6
  • Drug: rituximab / IDEC-C2B8
    500 mg/m2 Week 10 Day 1 and thereafter
Study Arms  ICMJE
  • Experimental: Arm A (Phase 1)
    Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM)
    Intervention: Drug: venetoclax
  • Experimental: Arm B (Phase 1)
    Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
    Intervention: Drug: venetoclax
  • Experimental: Arm C (Phase 1)
    Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML)
    Interventions:
    • Drug: azacitadine
    • Drug: venetoclax
  • Experimental: Arm D (Phase 2)
    Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL
    Interventions:
    • Drug: venetoclax
    • Drug: rituximab / IDEC-C2B8
    • Drug: rituximab / IDEC-C2B8
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 29, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2014)
24
Estimated Study Completion Date  ICMJE February 6, 2020
Estimated Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. Participants with other lymphoproliferative diseases can be considered in consultation with the AbbVie medical monitor
  • Relapsed or refractory multiple myeloma participants must have been previously treated with at least one prior line of therapy and have measurable disease
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma participants must have relapsed or be refractory to standard treatments such as fludarabine based regimens or alkylator based regimens
  • Untreated AML subjects or Relapsed or refractory AML subjects must have been previously treated with at least one prior line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1; adequate bone marrow independent of growth factor support per local laboratory reference range; and adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening
  • Participants with a history of autologous or allogenic stem cell transplantation must have adequate blood counts independent of growth factor support and have recovered from any transplant-related toxicity(s) and be at least 100 days post-autologous transplant (multiple myeloma) or 6 month post-autologous transplant (NHL) prior to first dose of study drug or at least 6 months post-allogenic transplant (multiple myeloma) prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment

Exclusion Criteria:

  • NHL participants who have undergone an allogeneic stem cell transplant or were diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia
  • Participant tested positive for HIV
  • Participant has a cardiovascular disability status of New York Heart Association Class greater or equal to 2
  • Participant has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
  • Participant received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02265731
Other Study ID Numbers  ICMJE M13-834
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 Genentech, Inc.
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date June 2019

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