A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
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ClinicalTrials.gov Identifier: NCT03069352 |
Recruitment Status :
Active, not recruiting
First Posted : March 3, 2017
Results First Posted : February 28, 2020
Last Update Posted : July 3, 2023
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Acute Myeloid Leukemia (AML) |
Interventions |
Drug: Placebo Drug: Venetoclax Drug: Cytarabine |
Enrollment | 211 |
Recruitment Details | Participants were enrolled at 76 sites globally. The study is currently ongoing; the results reported below include the primary analysis for efficacy which was conducted after 133 deaths occurred (data cut-off date of 15 February 2019), and an unplanned 6-month follow-up update for overall survival and safety (15 August 2019 cut-off date). |
Pre-assignment Details | Participants with acute myeloid leukemia (AML) were randomized to one of two treatment arms in a 1:2 ratio (placebo + low-dose cytarabine [LDAC] or venetoclax + LDAC). Randomization was stratified by AML status (secondary, de novo), age (18 - < 75, ≥ 75) and region (United States [US], European Union [EU], China, Japan, rest of world). |
Arm/Group Title | Placebo + Low Dose Cytarabine (LDAC) | Venetoclax + Low Dose Cytarabine (LDAC) |
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Arm/Group Description |
Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met. |
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met. |
Period Title: Overall Study | ||
Started | 68 | 143 |
Received Treatment | 68 | 142 |
Completed [1] | 56 | 103 |
Not Completed | 12 | 40 |
Reason Not Completed | ||
Ongoing | 12 | 40 |
[1]
As of 15 August 2019
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Arm/Group Title | Placebo + Low Dose Cytarabine (LDAC) | Venetoclax + Low Dose Cytarabine (LDAC) | Total | |
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Arm/Group Description | Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. | Total of all reporting groups | |
Overall Number of Baseline Participants | 68 | 143 | 211 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 68 participants | 143 participants | 211 participants | |
76.0
(41.0 to 88.0)
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76.0
(36.0 to 93.0)
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76.0
(36.0 to 93.0)
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 143 participants | 211 participants | |
18 to < 65 years |
9 13.2%
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11 7.7%
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20 9.5%
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65 to < 75 years |
19 27.9%
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50 35.0%
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69 32.7%
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≥ 75 years |
40 58.8%
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82 57.3%
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122 57.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 143 participants | 211 participants | |
Female |
29 42.6%
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65 45.5%
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94 44.5%
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Male |
39 57.4%
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78 54.5%
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117 55.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 143 participants | 211 participants | |
White |
47 69.1%
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102 71.3%
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149 70.6%
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Black or African American |
1 1.5%
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2 1.4%
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3 1.4%
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Asian |
20 29.4%
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39 27.3%
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59 28.0%
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Region
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 143 participants | 211 participants | |
United States |
6 8.8%
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13 9.1%
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19 9.0%
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European Union |
26 38.2%
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56 39.2%
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82 38.9%
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China |
6 8.8%
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9 6.3%
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15 7.1%
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Japan |
9 13.2%
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18 12.6%
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27 12.8%
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Rest of World |
21 30.9%
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47 32.9%
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68 32.2%
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[1]
Measure Description: Rest of World includes Australia, Brazil, Canada, New Zealand, Puerto Rico, Russia, South Africa, South Korea, and Taiwan.
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AML Status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 143 participants | 211 participants | |
De novo |
45 66.2%
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85 59.4%
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130 61.6%
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Secondary |
23 33.8%
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58 40.6%
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81 38.4%
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Name/Title: | Global Medical Services |
Organization: | AbbVie |
Phone: | 800-633-9110 |
EMail: | abbvieclinicaltrials@abbvie.com |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03069352 |
Other Study ID Numbers: |
M16-043 2016-003900-30 ( EudraCT Number ) |
First Submitted: | February 28, 2017 |
First Posted: | March 3, 2017 |
Results First Submitted: | February 14, 2020 |
Results First Posted: | February 28, 2020 |
Last Update Posted: | July 3, 2023 |