Research to Compare Tablet versus Intravenous Injection Azacitidine- Anticancer Drug in Patients with Acute Myeloid Leukemia blood cancer
Phase 2
- Conditions
- Health Condition 1: D728- Other specified disorders of whiteblood cells
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.18 years or older
2.AML/MDS Patients who are not a candidate for standard chemotherapy
3.ECOG Performance Status 0-3
4.Participants are willing to provide written informed consent.
Exclusion Criteria
1.Pregnant and Lactating women
2.Acute Promyelocytic Leukemia (APML)
3.Known Hypersensitivity to azacytidine
4.Known or active HIV, viral hepatitis B, or C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematologic complete remission after induction treatment with oral azacytidine (200 mg BD) for 21 days versus intravenous azacytidine (75 mg/m2/day) for 7 daysTimepoint: Timeline Day 30, Day 60, Day 90, Day 180
- Secondary Outcome Measures
Name Time Method Comparison of area under the curve AUC0-12 of oral azacytidine (200 mg BD) & intravenous azacytidine (75 mg/m2/day) <br/ ><br> <br/ ><br>Treatment-emergent adverse events (TEAEs) from first dose through 28 days <br/ ><br> <br/ ><br>Comparison of Proportion of subjects achieving RBC transfusion independence between oral versus intravenous groupTimepoint: Timeline Day 30, Day 60, Day 90, Day 180