Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: daunorubicin and cytarabine and venetoclax: 1. Daunorubicin intravenously over 30 min with doses 45 or 60 mg for 2 or 3 days
2. Cytarabine 100 mg/m2 subcutaneously over 3 to 5 min for
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of AML by WHO criteria 2. TLC less than or equal to twenty five thousand per cubic millimeter 3. Patients more than or equal to eighteen years 4. Eastern Cooperative Oncology Group (ECOG) performance status of zero to two 5. Newly diagnosed and relapsed (minimum of one prior line of AML directed therapy) to standard AML therapy will be eligible 6. Organ functions a.Renal function with creatinine clearance more than thirty milli litre per minute based on Cockcroft â?? gault equation b.Hepatic function including total bilirubin less than 1.5 times upper limit of normal unless increase is due to gilberts disease or leukemic involvement and AST and or ALT less than three times upper limit of normal unless considered due to leukemic involvement
Exclusion criteria
Exclusion criteria: 1. Infection with HIV or hepatitis B or C 2. Patients with NYHA class III or IV congestive heart failure 3. History of myocardial infection or unstable angina within last six months 4. Psychiatric illness that would adversely affect the participation in this study 5. Pregnant and lactating women 6. Baseline presentation with TLS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of induction, to assess the rate of composite complete remission (CRc) including CR and CRi according to the modified International Working Group response criteriaTimepoint: At the end of induction, at 28 days or at the time of count recovery, maximum to 42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Minimal residual disease by flow cytometry(MRD) 2.Adverse events(AEs) 3.Event free survival(EFS) 4.Overall survival(OS) 5.Induction mortality rates Timepoint: 1.MRD at the end of induction 2.adverse events through out the induction 3.EFS two years 4.OS two years 5.induction mortality rate at the end of induction | — |
Countries
India
Contacts
Public Contactsabitha P
all india institute of New Delhi
Outcome results
None listed