Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
Conditions
Interventions
Intervention1: Phase-1: Cohort-1
Inj Azacytidine
Inj Artesunate: Inj Azacytidine x 75mg/m2 per day for 7 days
Inj Artesunate x 2.4mg/kg per day x 7 days
the above will be repeated for every 28 days
Sponsors
India Alliance DBT Wellcome
Eligibility
Inclusion criteria
Inclusion criteria: Aged above 18 years of age Newly diagnosed de-novo acute myeloid leukaemia. ECOG performance score above 2 Adequate renal function: Glomerular Filtration Rate above 60ml/min Adequate hepatobiliary function: Total bilirubin less than 2 x Upper limit normal Adequate cardiac function with no past history of ischaemic heart disease and normal ejection fraction Female participants of child bearing potential must have a negative pregnancy test less than 72 hours prior to initiating study intervention and agree to avoid pregnancy using adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention Male participants with a partner of childbearing potential must agree to use adequate, medically approved contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention Patient able and willing to provide written, informed consent for the study.
Exclusion criteria
Exclusion criteria: Contraindication to the use of arsenic trioxide or artesunate due to hypersensitivity or past history of adverse events with these agents, or any other medical contraindication to administer these drugs Pregnancy or lactation Male or female participants unwilling to use an effective method of birth control (either hormonal in the form of the contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film); or agreement of true abstinence from time consent is signed until 6 weeks after the last dose of study treatment intervention (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation methods are not considered acceptable methods) 4. Evidence of sepsis with hemodynamic compromise at diagnosis History of immunosuppression History of hearing or balance problems Any other malignant disease diagnosis within the preceding 2 years with the exception of non- melanomatous skin cancer and carcinoma in situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best response rate (CR+iCR+MLFS) at end of 4 cycles of treatmentTimepoint: At 30 days At 60 days At 180 days and Once in a year | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD negative rate by flowcytometry (less than 0.01% with a sensitivity of 10-5) Event free survival defined as relapse or death due to any cause from date of enrolment in study Overall survival defined as death due to any cause from date of enrolment in studyTimepoint: At 30 days At 60 days At 180 days and Once in a year | — |
Countries
India
Contacts
Public ContactVikram Mathews
Christian Medical College Ranipet Campus
Outcome results
None listed