Clinical Trials /

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

NCT03941964

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Secondary Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M19-072
  • NCT ID: NCT03941964

Conditions

  • Acute Myeloid Leukemia (AML)
  • Cancer

Interventions

DrugSynonymsArms
venetoclaxABT-199Ventoclax + azacitidine or decitabine
azacytidineVidazaVentoclax + azacitidine or decitabine
decitabineDacogenVentoclax + azacitidine or decitabine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Ventoclax + azacitidine or decitabineExperimentalVenetoclax (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.
  • venetoclax
  • azacytidine
  • decitabine

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Composite Complete Remission Rate (CR + CRi)
Time Frame:Up to approximately 24 weeks
Safety Issue:
Description: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

Measure:Overall Response Rates (CR, CRi)
Time Frame:Up to approximately 24 weeks
Safety Issue:
Description: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.
Measure:Percent of Participants who Achieve Transfusion Independence
Time Frame:Up to at least 56 days after initial administration of study drug
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Acute Myeloid Leukemia (AML)
  • cancer
  • treatment naive
  • venetoclax
  • azacitidine
  • decitabine
  • outpatient setting

Last Updated

December 5, 2019