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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

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ClinicalTrials.gov Identifier: NCT03941964
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Cancer Drug: venetoclax Drug: azacytidine Drug: decitabine Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : August 15, 2019
Estimated Primary Completion Date : November 11, 2020
Estimated Study Completion Date : January 30, 2021

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Arms and Interventions
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Arm Intervention/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 Name: ABT-199

Drug: azacytidine
infusion; subcutaneous or intravenous
Other Name: Vidaza

Drug: decitabine
infusion; intravenous
Other Name: Dacogen


Outcome Measures
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Primary Outcome Measures :
  1. Composite Complete Remission Rate (CR + CRi) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941964


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Arizona
Arizona Oncology Associates, PC-HOPE /ID# 211509 Recruiting
Tucson, Arizona, United States, 85711-2701
United States, Colorado
Colorado Blood Cancer Institute /ID# 212800 Recruiting
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers /ID# 211508 Recruiting
Lone Tree, Colorado, United States, 80124
United States, Minnesota
Minnesota Oncology Hematology, /ID# 212837 Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Ohio
Oncology Hematology Care, Inc - Kenwood /ID# 212779 Recruiting
Cincinnati, Ohio, United States, 45236-2725
United States, Oregon
Willamette Valley Cancer Institute /ID# 211504 Recruiting
Eugene, Oregon, United States, 97401-6043
United States, South Carolina
Charleston Hematology Oncology Associates, PA /ID# 211471 Recruiting
Charleston, South Carolina, United States, 29414-7710
Greenville Health System - Int'l Dr /ID# 211466 Recruiting
Greenville, South Carolina, United States, 29615
United States, Tennessee
Tennessee Oncology - Chattanooga / McCallie /ID# 212717 Recruiting
Chattanooga, Tennessee, United States, 37404-3230
Tennessee Oncology-Nashville Centennial /ID# 210944 Recruiting
Nashville, Tennessee, United States, 37203-1632
United States, Texas
Texas Oncology - Austin Midtown /ID# 212780 Recruiting
Austin, Texas, United States, 78705
Texas Oncology - Dallas /ID# 211503 Recruiting
Dallas, Texas, United States, 75230
Texas Transplant Institute /ID# 213311 Not yet recruiting
San Antonio, Texas, United States, 78229
Texas Oncology - San Antonio Medical Center /ID# 211510 Recruiting
San Antonio, Texas, United States, 78240-5251
Texas Oncology - Tyler /ID# 213908 Recruiting
Tyler, Texas, United States, 75702
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03941964     History of Changes
Other Study ID Numbers: M19-072
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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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:
Acute Myeloid Leukemia (AML)
cancer
treatment naive
venetoclax
 azacitidine
decitabine
outpatient setting
Additional relevant MeSH terms:
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Venetoclax
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
 Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors