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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.

A clinical study to evaluate the safety and feasibility of outpatient induction therapy in newly diagnosed adolescent and adult acute myeloid leukemia (AML). - AML Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/027654
Enrollment
30
Registered
2020-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Tata Research Administrative Council TRAC
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To evaluate Induction mortality- death within 4 weeks after starting AML inductionTimepoint: 28 days

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Hasmukh Jain

Tata Memorial Centre

dr.hkjain@gmail.com02224177018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026