CTRI/2023/02/050069Not yet recruitingPhase 1
Venetoclax with chemotherapy for remission induction in AML patients a phase Ib/II study
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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