Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: AUR 103: 100 mg orally twice daily for entire duration of study. (02 Years).
Control Intervention1: NIL: NIL
Sponsors
Aurigene Oncology Limited
Aurigene Discovery Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of Acute myeloid leukemia (AML) according to the World Health Organization criteria. OR Myelodysplastic syndrome (MDS) according to the WHO classification. Provide signed and dated informed consent and agree to comply with all study related activities. ECOG status of 0 or 1.
Exclusion criteria
Exclusion criteria: Acute promyelocytic leukemia. Patients eligible for intensive chemotherapy for AML. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall safety profile of the combination AUR 103 Calcium + AZA in patients with AML or intermediate risk or high risk or very high-risk MDS. Efficacy assessed by response rates.Timepoint: Baseline, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks,36 weeks,40 weeks, 44 weeks, 48 weeks, 52 weeks and end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| remission according to ELN and IWG criteria.Timepoint: every 3 cycles | — |
Countries
India
Contacts
Public ContactDr Akhil Kumar
Aurigene Oncology Limited
Outcome results
None listed