Open Label 2-Arm Study of Venetoclax in Combination with Azacitidine Versus Best Supportive Care after Allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 435

Inclusion Criteria

Adult male or female = 18 years old for Part 1 and, male or female at least 12 years old for Part 2.
Subject 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 45 days.
Blast percentage in bone marrow prior to pre-transplant conditioning must be < 10%. Blast count in peripheral blood must be 0” and malignant Blast percentage in bone marrow must be < 5% after transplant within 7 days prior to Cycle 1 Day 1.
Bilirubin = 3 × ULN. Cycle 1 Day 1 must occur within 28 to 200 days after transplant and no later than 60 days since meeting count recovery criteria post-transplant.
Post-transplant count recovery (within 7 days prior to Cycle 1 Day 1) criteria: ANC measured twice at least 2 days apart and within one week from Cycle 1 Day 1. Subjects should not have granulocyte-colony stimulating factor (G-CSF) treatment for 7 days before first ANC count. (ANC value for Part 1 = 1,500/µL and = 1,000/µL for Part 2); Platelets should be measured twice at least 2 days apart and within 1 week from Cycle 1 Day 1.
Subjects should not have a platelet transfusion for 7 days before first platelet count. (value for Part 1 = 80,000/µL and = 50,000/µL for Part 2). Adequate renal function as demonstrated by a creatinine clearance >30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection and subjects 12-17 years old must have the equivalent as calculated by the Schwartz formula. Subjects = 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and subjects 12 - 16 years old must have a Lansky Play Performance Scale (LPPS) score > 40.
If a subject is 12-16 at the time of screening and turns 17 during the study, the subject will continue with the LPPS.
No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 305
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

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).
Known infection with HIV or subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV) with high viral titers.
Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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