Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Phase III
Arm A (Experimental): High-Dose Cytarabine (9 g per m total per cycle over 3 days) + Venetoclax 100 mg orally once daily (Days 1 10)
Three cycles
Intervention2: Phase II sing
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Denovo AML in morphological remission after azacitidine venetoclax based induction therapy Age 15 to 60 years ECOG performance status 0 to 1 A patient who can give informed consent for the study The patient does not have any contraindications to receive chemotherapy Adequate hematological hepatic and renal function parameters a Hematological Hb more than 80 g per L ANC more than or equal to 1.5 x 10 9 per L platelets more than or equal to 100 x 10 9 per L b Liver functions bilirubin less than or equal to 2 times upper limit normal ULN AST ALT less than or equal to 5 times ULN alkaline phosphatase less than or equal to 6 times ULN serum albumin more than or equal to 30 g per L c Renal function creatinine less than or equal to 1.5 ULN creatinine clearance more than or equal to 60 mL per min Written patient consent form
Exclusion criteria
Exclusion criteria: Very high risk AML TP53 mutated AML Complex karyotype Monosomal karyotype AML with FLT3 mutation VAF greater than 5 percent Complete remission with incomplete hematologic recovery CRi More than 6 weeks since the last azacitidine venetoclax Active infection requiring IV antibiotics or antifungals Clinically significant active coronary heart disease cardiomyopathy or congestive heart failure NYHA III IV clinically significant valvular defect ECOG PS 2 or more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-Free Survival (EFS)Timepoint: Participants will be followed for 24 months after completion of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS)Timepoint: Time from randomization to relapse, progression, or death from any cause.;Overall Survival (OS)Timepoint: Time from randomization to relapse, progression, or death from any cause.;Incidence of Grade 3 4 toxicities (CTCAE v5.0)Timepoint: Time from randomization to relapse, progression, or death from any cause.;MRD clearance kinetics (NGS-based)Timepoint: Time from randomization to relapse, progression, or death from any cause. | — |
Countries
India
Contacts
Public ContactDr Lingaraj Nayak
Tata Memorial Centre
Outcome results
None listed