Modified Weekly induction split treatment schedule in AML

Tolerability adapted Induction Regimen (weekly daunorubicin and cytarabine) for newly diagnosed borderline fit Acute Myeloid Leukemia: a Pilot study of safety (induction mortality rate and toxicity profile) and efficacy (remission rate) - TAMe AML

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035528

Enrollment

Registered

2021-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: WEEKLY DAUNORUBICIN AND CYTARABINE IN AML: Cytarabine and daunorubicin will be delivered in a modified way that is instead of delivering the full dose within 7 days, doses will be split

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed treatment naive AML patients with 1.age 18 to 60 years, 2.Eastern Co-operative Group (ECOG) performance score 2 or 3 3.Serum creatinine 4.Serum bilirubin 5.Normal 2D echocardiogram

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.Secondary AML 2.Patients with HIV 3.Patients with pregnancy or lactating females 4.Patients deemed to be fit for intensive AML induction as per physicianâ??s discretion 5.Patients with septic shock, extensive pneumonia, or who are deemed to be unfit for any anticancer therapy as per physicianâ??s discretion

Design outcomes

Primary

Measure	Time frame
In young borderline fit newly diagnosed AML patients treated with the experimental regimen (of weekly daunorubicin and cytarabine), to assess the following during the course and at the end of induction: 1. Complete remission (CR) rates 2. Toxicity profile 3. Mortality rate Timepoint: After two courses of weekly Daunorubicin and cytarabine has been delivered, and until week 8 from the initiation of experimental therapy or beginning of next phase of therapy.	—

Measure

Time frame

In young borderline fit newly diagnosed AML patients treated with the experimental regimen (of weekly daunorubicin and cytarabine), to assess the following during the course and at the end of induction: 1. Complete remission (CR) rates 2. Toxicity profile 3. Mortality rate Timepoint: After two courses of weekly Daunorubicin and cytarabine has been delivered, and until week 8 from the initiation of experimental therapy or beginning of next phase of therapy.

—

Secondary

Measure	Time frame
1. To study the LFS (leukemia free survival) and OS (overall survival) in young borderline fit newly diagnosed AML treated with the experimental regimen (of weekly daunorubicin and cytarabine) 2. To assess the utility of a physical performance test (modified 3 min walk test) in defining fitness for young adults with newly diagnosed AML and to find association of the test results with the physicianâ??s discretion for fitness level ans to study the concordance between the two. Timepoint: 2 years	—

Measure

Time frame

1. To study the LFS (leukemia free survival) and OS (overall survival) in young borderline fit newly diagnosed AML treated with the experimental regimen (of weekly daunorubicin and cytarabine) 2. To assess the utility of a physical performance test (modified 3 min walk test) in defining fitness for young adults with newly diagnosed AML and to find association of the test results with the physicianâ??s discretion for fitness level ans to study the concordance between the two. Timepoint: 2 years

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Countries

India

Contacts

Public ContactDR Karthikeyan R

Jawaharlal Institute of Postgraduate Medical Education and Research

gandhikrishnan02@gmail.com8754650015

Outcome results

None listed

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