Health Condition 1: D728- Other specified disorders of whiteblood cells
Conditions
Interventions
Intervention1: ORAL AZACITIDINE ARM
: 200 mg BD for 21 days in a 28 day Cycle
Control Intervention1: IV AZACITIDINE ARM
: 75 mg / m2/day for 7 days in a 28 day cycle
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Comparison of area under the curve AUC0-12 of oral azacytidine (200 mg BD) & intravenous azacytidine (75 mg/m2/day) Treatment-emergent adverse events (TEAEs) from first dose through 28 days Comparison of Proportion of subjects achieving RBC transfusion independence between oral versus intravenous groupTimepoint: Timeline Day 30, Day 60, Day 90, Day 180 | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactProf Smita pattanaik
PGIMER, Chandigarh
Outcome results
None listed