Clinical Trials List
Protocol NumberM19-708
NCT Number(ClinicalTrials.gov Identfier)NCT04102020
2019-12-01 - 2025-06-16
Phase III
Recruiting4
ICD-10C92.A1
Acute myeloid leukemia with multilineage dysplasia, in remission
Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 高小雯 無
- Hung Chang 無
- Tung-Liang Lin 無
- 蘇羿囷 無
- Po-Nan Wang 無
- 歐哲瑋 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Huai-Hsuan Huang 無
- MING YAO 無
- - - 無
- 田豐銘 無
- Jih-Luh Tang 未分科
- Chieh-Lung Cheng 無
- HSIN-AN HOU 無
- 劉家豪 無
- CHENG-HONG TSAI 無
- Chien-Chin Lin 無
- Sheng-chieh Chou 無
- - - 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 唐世豪 未分科
- Tsung-Jang Yeh 無
- Jeng-Shiun Du 無
- Hui-Ching Wang 未分科
- 高育青 無
- Yi-Chang Liu 無
- Shih-Feng Cho 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Acute Myeloid Leukemia (AML)
Objectives
The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of venetoclax in combination with AZA. Part 2 will be the randomization portion to evaluate if venetoclax in combination with AZA as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month. Part 3 will be the Dose Finding portion to determine levels of venetoclax in combination with Azacitidine (CC-486) to be explored. CC-486, and BSC may be administered for up to 24 cycles.
Test Drug
Venetoclax
Venetoclax
Venetoclax
Active Ingredient
Venetoclax
Venetoclax
Venetoclax
Dosage Form
tablet
tablet
tablet
Dosage
10mg/tab
50mg/tab
100mg/tab
10mg/tab
50mg/tab
100mg/tab
50mg/tab
100mg/tab
10mg/tab
50mg/tab
100mg/tab
Endpoints
Primary Outcome Measures :
Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1) [ Time Frame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months ]
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Relapse-Free Survival (RFS) (Part 2) [ Time Frame: Time from treatment to relapse or death from any cause, up to approximately 3 years ]
RFS is defined as the number of days from randomization to the date of relapse or the date of death from any cause, whichever comes first.
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3) [ Time Frame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months ]
DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.
Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1) [ Time Frame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months ]
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Relapse-Free Survival (RFS) (Part 2) [ Time Frame: Time from treatment to relapse or death from any cause, up to approximately 3 years ]
RFS is defined as the number of days from randomization to the date of relapse or the date of death from any cause, whichever comes first.
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3) [ Time Frame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months ]
DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.
Inclution Criteria
Inclusion Criteria:
Diagnosis of newly diagnosed acute myeloid leukemia (AML).
Participant meets the following disease activity criteria:
Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of planned induction and consolidation chemotherapy.
Achieved first CR + CRi within 4 months of enrollment or be no more than 75 days since last dose of conventional therapy.
AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Diagnosis of newly diagnosed acute myeloid leukemia (AML).
Participant meets the following disease activity criteria:
Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of planned induction and consolidation chemotherapy.
Achieved first CR + CRi within 4 months of enrollment or be no more than 75 days since last dose of conventional therapy.
AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria
Exclusion Criteria:
History of acute promyelocytic leukemia (APL).
History of active central nervous system involvement with acute myeloid leukemia (AML).
History of acute promyelocytic leukemia (APL).
History of active central nervous system involvement with acute myeloid leukemia (AML).
The Estimated Number of Participants
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Taiwan
20 participants
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Global
360 participants
