A study proposed to evaluate the safety of induction chemotherapy as a outpatient setting in adults and young adults newly diagnosed with AML type of blood cancer.
Not Applicable
Completed
- Conditions
- Health Condition 1: C920- Acute myeloblastic leukemia
- Registration Number
- CTRI/2020/09/027654
- Lead Sponsor
- Tata Research Administrative Council TRAC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Newly diagnosed AML and high-risk myelodysplastic syndrome.
2. Planned treatment with Cytarabine and daunomycin with or without midostaurin
3. Normal organ function and no active infection in lungs
4. Accommodation facility within one hour distance from hospital.
Exclusion Criteria
1. platelet count less than 10000 after 1 unit SDP transfusion
2. Clinical internal/visceral bleeding manifestations like hematemesis, melaena, hematuria
3. History of hypersensitivity/ allergy to blood/ blood products, chemotherapeutic drugs and antibiotics
4. Acute medical emergencies like diabetic ketosis, diabetic ketoacidosis, hypertensive urgency/ emergency, acute kidney injury etc
5. Relapsed AML case patients
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate Induction mortality- death within 4 weeks after starting AML inductionTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method 1.To access complete remission rates and readmission rates. To decrease the time from diagnosis of AML to treatment initiation. Incidence of noncompliance among the OPD follow up patients with regard to scheduled visit follow up. To access progression free survival at 2 yearsTimepoint: 2 years