A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03941964
Collaborator
(none)
54
Enrollment
16
Locations
1
Arm
32.4
Anticipated Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Single-Arm, Multicenter Open-Label Study of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in AML Patients Ineligible for Intensive Chemotherapy
Actual Study Start Date :
Aug 15, 2019
Anticipated Primary Completion Date :
Jan 26, 2022
Anticipated Study Completion Date :
Apr 27, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ventoclax + azacitidine or decitabine

Venetoclax (daily for 28 days), in combination with azacitidine or decitabine, beginning on Cycle 1 Day 1. Depending on investigator's choice, participants will receive either azacitidine for 7 days beginning on Day 1 of each 28-day cycle or decitabine for 5 days beginning on Day 1 of each 28-day cycle, as per institutional practice.

Drug: venetoclax
tablet; oral
Other Names:
  • ABT-199
  • Drug: azacytidine
    infusion; subcutaneous or intravenous
    Other Names:
  • Vidaza
  • Drug: decitabine
    infusion; intravenous
    Other Names:
  • Dacogen
  • Outcome Measures

    Primary Outcome Measures

    1. Composite Complete Remission Rate (CR + CRi) [Up to approximately 24 weeks]

      The Composite Complete Remission Rate (CR + CRi) is defined as the proportion of participants who achieve complete remission (CR) plus participants who achieve complete remission with incomplete hematologic recovery (CRi) as described by the modified International Working Group (IWG) criteria for Acute Myeloid Leukemia (AML).

    Secondary Outcome Measures

    1. Overall Response Rates (CR, CRi) [Up to approximately 24 weeks]

      Overall Response Rates to treatment is the proportion of participants who achieve complete remission or complete remission with incomplete hematologic recovery, based on guidelines adapted from the IWG for AML.

    2. Percent of Participants who Achieve Transfusion Independence [Up to at least 56 days after initial administration of study drug]

      Transfusion Independence: the rate of red blood cell (RBC) and platelet transfusion dependence (defined as having received ≥ 2 units of RBCs and/or platelets within 56 days prior to study) at baseline and assess transfusion independence, defined as at least 56 consecutive days without a RBC or platelet transfusion during the treatment period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participant has confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria.

    • Participant is deemed by the investigator to be an appropriate candidate for outpatient ramp-up of venetoclax.

    • Participant is not eligible to receive treatment with standard cytarabine and anthracycline induction regimens.

    • Participant has not received prior treatment for AML (treatment naïve) with the exception of hydroxyurea.

    • Participant has no evidence of spontaneous tumor lysis syndrome (TLS) at Screening.

    • Participant can have progressed from myelodysplastic syndrome (MDS) or be considered to have secondary AML and could have been treated with growth factors or other agents with the exception of hypomethylating agents.

    • Participant has adequate kidney, liver and hematology laboratory values as detailed in the protocol.

    • Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 3.

    Exclusion Criteria:
    • Has a history of the following conditions:

    • Acute promyelocytic leukemia

    • Known active central nervous system involvement with AML

    • Positive for HIV (HIV testing is not required)

    • Positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months

    • Cardiovascular disability status of New York Heart Association Class > 2

    • Chronic respiratory disease that requires continuous oxygen or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study

    • Malabsorption syndrome or other condition that precludes enteral route of administration

    Has a history of other malignancies within 2 years prior to study entry, with the exception of:

    • Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast

    • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin

    • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Arizona Oncology Associates, PC-HOPE /ID# 211509TempeArizonaUnited States85284-1812
    2Colorado Blood Cancer Institute /ID# 212800DenverColoradoUnited States80218
    3Rocky Mountain Cancer Centers /ID# 211508Lone TreeColoradoUnited States80124
    4Fort Wayne Medical Oncology /ID# 223523Fort WayneIndianaUnited States46804
    5Minnesota Oncology Hematology, PA /ID# 212837MinneapolisMinnesotaUnited States55404
    6Oncology Hematology Care, Inc - Kenwood /ID# 212779CincinnatiOhioUnited States45236-2725
    7Willamette Valley Cancer Institute /ID# 211504EugeneOregonUnited States97401-6043
    8Charleston Oncology, P.A. /ID# 211471CharlestonSouth CarolinaUnited States29414-7710
    9Prisma Health Cancer Inst - Eastside /ID# 211466GreenvilleSouth CarolinaUnited States29615
    10Tennessee Oncology - Chattanooga / McCallie /ID# 212717ChattanoogaTennesseeUnited States37404-3230
    11Tennessee Oncology-Nashville Centennial /ID# 210944NashvilleTennesseeUnited States37203-1632
    12Texas Oncology - Austin Midtown /ID# 212780AustinTexasUnited States78705
    13Texas Oncology - Medical City Dallas /ID# 211503DallasTexasUnited States75230
    14Texas Transplant Institute /ID# 213311San AntonioTexasUnited States78229
    15Texas Oncology - San Antonio Medical Center /ID# 211510San AntonioTexasUnited States78240-5251
    16Texas Oncology - Tyler /ID# 213908TylerTexasUnited States75702

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03941964
    Other Study ID Numbers:
    • M19-072
    First Posted:
    May 8, 2019
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021