Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: venetoclax in combination with
azacitidine (AZA): This is a Phase 4, open-label, single-arm, multicenter study In India evaluating the safety and efficacy of venetoclax in combination w
Sponsors
AbbVie
AbbVie Healthcare India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Consent Subjects if judged by the investigator to have decision-making capacity must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. Demographic and Laboratory Assessments Subject must be of Indian descent and reside in India. Adult subject must be at least 18 years old. Subject must have a projected life expectancy of at least 12 weeks Subject must have confirmation of AML by 2016 WHO criteria, has not received previous treatment for AML, and is ineligible for treatment with intensive chemotherapy as defined by the following: Greater than or equal to 75 years of age or between18 to 74 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3, Cardiac history of congestive heart failure requiring treatment or ejection fraction less than or equal to 50% or chronic stable angina, Diffusing capacity of the lung for carbon monoxide (DLCO) less than or equal to 65% or forced expiratory volume during the first second (FEV1) less than or equal to 65%, Creatinine clearance greater than or equal to 30 mL/min to less than 45 mL/min, Moderate hepatic impairment with total bilirubin greater than 1.5 to less than or equal to 3.0 ULN, Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: Creatinine clearance greater than or equal to 30 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Adequate liver function as demonstrated by: Serum aspartate aminotransferase (AST) less than or equal to 3.0 upper limit of normal (ULN), Serum alanine aminotransferase (ALT) less than or equal to 3.0 ULN, Total bilirubin less than or equal to 1.5 ULN Unless considered due to leukemic organ involvement, White blood cell (WBC) count less than 25 109 /L (hydroxyurea is permitted to meet this criterion) Subject is willing and able to comply with procedures required in this protocol. Disease/Condition Activity Subject must have ECOG performance status of: 0 to 2 for subjects greater than or equal to 75 years of age or 0 to 3 for subjects greater than or equal to18 to 74 years of age Subject meets the following disease activity criteria: Has not received any prior treatment for AML, with the exception of hydroxyurea, May have progressed from myelodysplastic syndrome (MDS) or be considered to have secondary AML and could have been treated with growth factors only. Contraception Pregnancy testing in female subjects of childbearing potential: Subjects must have a negative serum pregnancy test at the Screening Visit and, if more than 7 days since obtaining the serum test, a negative urine pregnancy test at Cycle 1 Day 1, prior to the first dose of study drug. Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test greater than or equal to 3 days later to document continued lack of a positive result (unless prohibited by local requirements). Subjects with a urine pregnancy test at Baseline that is bor
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of venetoclax in combination with azacitidine during the study treatment in adult Indian subjects with newly diagnosed AML ineligible for intensive chemotherapy.Timepoint: 1. Outcome (parameter to be measurable) : Treatment-emergent Adverse Event (TEAE), Time points: Dec 2027 (End of study) 2. Outcome (parameter to be measurable) : Tumor Lysis Syndrome (TLS) during cycle 1, Time points: 1 month 3. Outcome (parameter to be measurable) : Laboratory abnormalities, Time points: Dec 2027 (End of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of venetoclax in combination with azacitidine including composite complete remission (complete remission [CR] & complete remission with incomplete marrow recovery [CRi]) in this population. 2. To evaluate the efficacy of venetoclax in combination with azacitidine by CR in this population. 3. To evaluate Overall survival (OS) in this population. Timepoint: 1. Outcome: Composite Complete Remission (CRc), Time points: Dec 2027 (End of study) 2. Outcome: Composite Complete Remission (CRc) by initiation of Cycle 2, Time points: 1 month 3. Outcome: Complete Remission (CR), Time points: Dec 2027 (End of study) 4. Outcome: Overall Survival (OS), Time points: Dec 2027 (End of study) | — |
Countries
India
Contacts
Public ContactNagaraj Malipatil
AbbVie
Outcome results
None listed