A randomized, open-label phase 3 study of the safety and efficacy of Venetoclax in combination with Azacitidine in patients with Acute Myeloid Leukemia (AML) after stem cell transplantation
Summary description of the study
Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (white blood cells responsible for fighting infections). Successful treatment of AML depends on the subtype of AML the patient has and the age of the patient at diagnosis. Venetoclax is a medication that kills cancer cells by blocking a protein (a part of a cell) that allows cancer cells to stay alive. The aim of the study is to investigate the safety and efficacy of Venetoclax and Azacitidine compared to Best Supportive Care (BSC) in patients with AML after allogeneic stem cell transplantation.
(BASEC)
Intervention under investigation
This study will be conducted in 17 countries and will enroll approximately 424 adolescent and adult participants with AML after a transplantation in part 1 and part 2 of the study. Adolescent participants will only be included in part 2. Approximately 24 participants will be included in part 1 of the study.
The study consists of two parts: In part 1, the safety and dosing of Venetoclax will be established. Part 2 of the study will focus on the efficacy of Venetoclax and Azacitidine compared to BSC after stem cell transplantation. During visits, various assessments will be conducted, including physical examination, blood tests, bone marrow samples, questionnaires, and vital signs. The total duration of the study will depend on patient recruitment, currently estimated at approximately 7 years.
(BASEC)
Disease under investigation
Acute Myeloid Leukemia (AML)
(BASEC)
1. Participants (men or women) must be at least 18 years old for part 1 and at least 12 years old for part 2. 2. Participants must have AML according to World Health Organization (WHO) criteria. Additionally, either an allogeneic stem cell transplantation must be planned or must have been performed within the last 14 days. 3. Blast count in the bone marrow prior to transplantation <10%. (BASEC)
Exclusion criteria
1. Progressive disease under prior treatment with Venetoclax. 2. History of another malignant disease within 2 years prior to study initiation, except: appropriately treated in situ carcinoma of the cervix or breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignant diseases that were resected with curative intent; myelodysplastic syndrome. 3. Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy. (BASEC)
Trial sites
Basel, Zurich
(BASEC)
Sponsor
AbbVie AG Cham
(BASEC)
Contact
Contact Person Switzerland
AbbVie Medical Information
+41 41 399 16 89
medinfo@clutterabbvie.comAbbVie AG
(BASEC)
General Information
AbbVie
(ICTRP)
Scientific Information
AbbVie
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
31.01.2020
(BASEC)
ICTRP Trial ID
NCT04161885 (ICTRP)
Official title (approved by ethics committee)
M19-063: 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) (BASEC)
Academic title
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) (ICTRP)
Public title
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML) (ICTRP)
Disease under investigation
Acute Myeloid Leukemia (AML)Cancer (ICTRP)
Intervention under investigation
Drug: VenetoclaxDrug: AzacitidineOther: Best Supportive Care (BSC) (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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 Acute Myeloid Leukemia (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 60 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:
- 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, Myeloproliferative
neoplasm (only allowed if it transformed to AML and AML should be the indication for
marrow transplantation).
- 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. (ICTRP)
not available
Primary and secondary end points
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1);Overall Survival (OS) (Part 2) (ICTRP)
Morphologic Relapse-Free Survival (RFS) (Part 2);Composite Relapse-Free Survival (RFS) (Part 2);Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2);Graft-versus-Host Disease (GvHD) Rate (Part 2);Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2);Change From Randomization in Fatigue in Adult Participants (Part 2);Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2);Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2);Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L) (ICTRP)
Registration date
11.11.2019 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
ABBVIE INC., AbbVie (ICTRP)
Secondary trial IDs
2023-507222-17-00, M19-063 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04161885 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available