A Phase 1b/2 Study of the drug venetoclax in combination with induction chemotherapy(ara-c and daunorubicin)in patients with newly diagnosed or relapsed/refractory AML.

Phase 1

Conditions: Health Condition 1: C920- Acute myeloblastic leukemia

Registration Number: CTRI/2023/02/050069

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.Minimal residual disease by flow cytometry(MRD) <br/ ><br>2.Adverse events(AEs) <br/ ><br>3.Event free survival(EFS) <br/ ><br>4.Overall survival(OS) <br/ ><br>5.Induction mortality rates <br/ ><br>Timepoint: 1.MRD at the end of induction <br/ ><br>2.adverse events through out the induction <br/ ><br>3.EFS two years <br/ ><br>4.OS two years <br/ ><br>5.induction mortality rate at the end of induction