Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia (AML) Cancer | Drug: venetoclax Drug: azacytidine Drug: decitabine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 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 : | August 15, 2019 |
Estimated Primary Completion Date : | January 26, 2022 |
Estimated Study Completion Date : | February 8, 2022 |
Arm | Intervention/treatment |
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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.
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Drug: venetoclax
tablet; oral
Other Name: ABT-199
Drug: azacytidine infusion; subcutaneous or intravenous
Other Name: Vidaza
Drug: decitabine infusion; intravenous
Other Name: Dacogen
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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 |
Inclusion Criteria:
Exclusion Criteria:
- Has a history of the following conditions:
Has a history of other malignancies within 2 years prior to study entry, with the exception of:
Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
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 | Completed |
Denver, Colorado, United States, 80218 | |
Rocky Mountain Cancer Centers /ID# 211508 | Recruiting |
Lone Tree, Colorado, United States, 80124 | |
United States, Indiana | |
Fort Wayne Medical Oncology /ID# 223523 | Recruiting |
Fort Wayne, Indiana, United States, 46804 | |
United States, Minnesota | |
Minnesota Oncology Hematology, PA /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 - Medical City Dallas /ID# 211503 | Recruiting |
Dallas, Texas, United States, 75230 | |
Texas Transplant Institute /ID# 213311 | 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 |
Study Director: | AbbVie Inc. | AbbVie |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | May 3, 2019 | ||||||||||||||||
First Posted Date ICMJE | May 8, 2019 | ||||||||||||||||
Last Update Posted Date | December 10, 2020 | ||||||||||||||||
Actual Study Start Date ICMJE | August 15, 2019 | ||||||||||||||||
Estimated Primary Completion Date | January 26, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | 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 ICMJE | 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 | ||||||||||||||||
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. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
60 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | February 8, 2022 | ||||||||||||||||
Estimated Primary Completion Date | January 26, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: - Has a history of the following conditions:
Has a history of other malignancies within 2 years prior to study entry, with the exception of:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03941964 | ||||||||||||||||
Other Study ID Numbers ICMJE | M19-072 | ||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | AbbVie | ||||||||||||||||
Study Sponsor ICMJE | AbbVie | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | AbbVie | ||||||||||||||||
Verification Date | December 2020 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |