A study to find new treatments for patients with blood cancers

Phase 1

Conditions: Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Registration Number: CTRI/2024/03/063617

Lead Sponsor: India Alliance DBT Wellcome

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best response rate (CR+iCR+MLFS) at end of 4 cycles of treatmentTimepoint: At 30 days <br/ ><br>At 60 days <br/ ><br>At 180 days and <br/ ><br>Once in a year

Secondary Outcome Measures

Name	Time	Method
MRD negative rate by flowcytometry (less than 0.01% with a sensitivity of 10-5) <br/ ><br>Event free survival defined as relapse or death due to any cause from date of <br/ ><br>enrolment in study <br/ ><br>Overall survival defined as death due to any cause from date of enrolment in studyTimepoint: At 30 days <br/ ><br>At 60 days <br/ ><br>At 180 days and <br/ ><br>Once in a year