Acute Myeloid Leukemia (AML)
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 14 days. Blast percentage in bone marrow before transplant must be 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 score > 40. Are the trial subjects under 18? yes Number of subjects for this age range: 19 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 325 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part I: To determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in AML patients when given as maintenance therapy following allogeneic stem cell transplantation. Part II: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;Secondary Objective: *To confirm the safety of venetoclax in combination with azacitidine after allogeneic transplantation in subjects diagnosed with AML. *To determine the efficacy of venetoclax in combination with azacitidine on overall survival. *To determine the effect of venetoclax in combination with azacitidine on the frequency and severity of GvHD. *To determine the effect of venetoclax in combination with azacitidine on Quality of life (QoL).;Primary end point(s): Part I: The primary endpoint is the frequency of DLTs of venetoclax in combination with azacitidine Part II: Relapse-Free Survival (RFS) ;Timepoint(s) of evaluation of this end point: Part I: the first treatment cycle (28 days). Part II:The time from randomization to the date of relapse or the date of death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Survival (OS) • GvHD-free, relapse free survival (GRFS). • Time to deterioration in Global Health Status (GHS)/QoL • GvHD rate at 90 days after randomization • Fatigue Change in adult subjects • Patient Reported Outcome (PRO) using Patient Reported Outcomes • Minimal residual disease (MRD) response rate;Timepoint(s) of evaluation of this end point: Overall Survival (OS)-time from randomization to death(any reason) GvHD-free,relapse free survival(GRFS)-time from randomization to a) disease relapse, b)occurrence or worsening of GvHD, or c)death(any reason) Time to deterioration using GHS/QoL in adult subjects-randomization to either deterioration of =5 points based on EORTC QLQ-C30(v3)or death (any cause) GvHD rate at 90 days after randomization-Grade 2 or higher for aGvHD and moderate/severe for cGvHD per investigator Fatigue Change in adult subjects-using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a. Difference between randomization and 6 months of treatment MRD response rate-only among subjects with MRD > 10-3 at study start; response is MRD conversion to < 10-3 after treatment start. | — |
Countries
Australia, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed