Clinical Trials List
Protocol NumberM19-063
NCT Number(ClinicalTrials.gov Identfier)NCT04161885
Active
2020-01-11 - 2027-12-31
Phase III
Recruiting6
ICD-10C92.A0
Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Hui-Ching Wang 無
- Yi-Chang Liu 無
- Jeng-Shiun Du 無
- Shih-Feng Cho 無
- 唐世豪 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 田豐銘 無
- Chieh-Lung Cheng 無
- MING YAO 無
- Chien-Chin Lin 無
- Jih-Luh Tang 無
- HSIN-AN HOU 無
- 劉家豪 無
- CHENG-HONG TSAI 無
- Huai-Hsuan Huang 無
- YAO CHI-YUAN 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Jen Liu 無
- Ting-An Lin 無
- Jyh-Pyng Gau 無
- Hao-Yuan Wang 無
- 蔡淳光 無
- Liang-Tsai Hsiao 無
- Po-Shen Ko 無
- 陳玟均 無
- Sheng-Hsuan Chien 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML)
Objectives
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).
This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).
Test Drug
VenetoclaxVenetoclax
Active Ingredient
Venetoclax
Venetoclax
Venetoclax
Venetoclax
Venetoclax
Venetoclax
Venetoclax
Venetoclax
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) Following Administration of Venetoclax and Azacitidine (Part 1) [ Time Frame: Upto the first treatment cycle (28 days) ]
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.
Relapse-Free Survival (RFS) (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
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.
Secondary Outcome Measures :
Overall Survival (OS) (Part 2) [ Time Frame: Up to 45 months after the first participant is randomized ]
OS is defined as the number of days from the date of randomization to the date of death from any cause.
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR occurrence or worsening of GvHD OR death from any cause.
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
Time to deterioration defined as number of days from randomization to either deterioration of >= 5 points based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 or death due to any cause.
Graft-versus-Host Disease (GvHD) rate (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
GvHD rate is defined as grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator
Change From Randomization in Fatigue in Adult Participants (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.
Minimal Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1) [ Time Frame: Upto the first treatment cycle (28 days) ]
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.
Relapse-Free Survival (RFS) (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
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.
Secondary Outcome Measures :
Overall Survival (OS) (Part 2) [ Time Frame: Up to 45 months after the first participant is randomized ]
OS is defined as the number of days from the date of randomization to the date of death from any cause.
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR occurrence or worsening of GvHD OR death from any cause.
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
Time to deterioration defined as number of days from randomization to either deterioration of >= 5 points based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 or death due to any cause.
Graft-versus-Host Disease (GvHD) rate (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
GvHD rate is defined as grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator
Change From Randomization in Fatigue in Adult Participants (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.
Minimal Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2) [ Time Frame: Up to 39 months after the first participant is randomized ]
MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.
Inclution Criteria
Inclusion Criteria:
Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
Participant must be diagnosed with AML by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 14 days.
Blast percentage in bone marrow before transplant must be < 10%.
Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.
Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
Participant must be diagnosed with AML by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 14 days.
Blast percentage in bone marrow before transplant must be < 10%.
Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.
Exclusion Criteria
Exclusion Criteria:
History of disease progression during prior treatment with venetoclax.
History of any other malignancy within 2 years prior to study entry, except for: 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; Myelodysplastic Syndrome.
Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.
History of disease progression during prior treatment with venetoclax.
History of any other malignancy within 2 years prior to study entry, except for: 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; Myelodysplastic Syndrome.
Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
424 participants
