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
NCT ID: NCT03941964
Last Updated: 2023-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2019-08-15
2022-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Venetoclax 400 mg + azacitidine 75 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
Venetoclax
Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.
Azacitidine
The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.
Venetoclax 400 mg + decitabine 20 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
Venetoclax
Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.
Decitabine
The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.
Interventions
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Venetoclax
Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.
Azacitidine
The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.
Decitabine
The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
12 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Texas Oncology - Austin Midtown /ID# 212780
Austin, Texas, United States
Texas Oncology - Medical City Dallas /ID# 211503
Dallas, Texas, United States
Texas Transplant Institute /ID# 213311
San Antonio, Texas, United States
Texas Oncology - San Antonio Medical Center /ID# 211510
San Antonio, Texas, United States
Texas Oncology - Northeast Texas /ID# 213908
Tyler, Texas, United States
Arizona Oncology Associates, PC-HOPE /ID# 211509
Tempe, Arizona, United States
Colorado Blood Cancer Institute /ID# 212800
Denver, Colorado, United States
Rocky Mountain Cancer Centers /ID# 211508
Lone Tree, Colorado, United States
Fort Wayne Medical Oncology /ID# 223523
Fort Wayne, Indiana, United States
Minnesota Oncology Hematology, PA /ID# 212837
Minneapolis, Minnesota, United States
Oncology Hematology Care, Inc. /ID# 212779
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center /ID# 211504
Eugene, Oregon, United States
Charleston Oncology, P.A. /ID# 211471
Charleston, South Carolina, United States
Prisma Health Cancer Inst - Eastside /ID# 211466
Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga / McCallie /ID# 212717
Chattanooga, Tennessee, United States
Tennessee Oncology-Nashville Centennial /ID# 210944
Nashville, Tennessee, United States
Countries
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References
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Manda S, Anz BM 3rd, Benton C, Broun ER, Yimer HA, Renshaw JS, Geils G Jr, Berdeja J, Cruz J, Melear JM, Fanning S, Fletcher L, Li Y, Duan Y, Werner ME, Potluri J, Pai MV, Donnellan WB. A phase 3b study of venetoclax and azacitidine or decitabine in an outpatient setting in patients with acute myeloid leukemia. Hematol Oncol. 2024 May;42(3):e3274. doi: 10.1002/hon.3274.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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M19-072
Identifier Type: -
Identifier Source: org_study_id
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