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Will Metronomic therapy prolong survival in nonfit for intensive chemotherapy acute myeloid leukemia patients? A randomized, controlled trial

Will Metronomic therapy prolong survival in nonfit for intensive chemotherapy acute myeloid leukemia patients? A randomized, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20150918001
Enrollment
Unknown
Registered
2015-09-18
Start date
2015-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

acute myeloid leukemia acute myeloid leukemia

Interventions

dose at initial: Etoposide 50 mg/m2 + 6MP 60 mg/m2+ prednisolone 40mg/m2 PO OD 21 days q 28 days * 4 cycles Evaluate response at 2 and 4 cycles current dose: Etoposide (25 mg) (5 days) BSA (1.0&#45
1.49) 1X2 BSA (1.5&#45
1.8) 1x3 6MP (50 mg) (2 wk) BSA (1.0&#45
1.49) 1X1 BSA (1.5&#45
1.8) 1x1 prednisolone (5 mg) (2wk) BSA (1.0&#45
1.49) 2X1 BSA (1.5&#45
1.8) 2x2,Hydroxyurea to keep the white blood cell less than 10&#44
000 cell/μL
Experimental Drug,Active Comparator Drug
metronomic,hydroxyurea

Sponsors

medicine department, Udonthani Hospital
Lead Sponsor
Udonthani hospital
Collaborator

Eligibility

Sex/Gender
All
Age
55 Years to 105 Years

Inclusion criteria

Inclusion criteria: 1. The patients who diagnosed acute myeloid leukemia 2. Performance status 0-3 or 4 due to acute leukemia, not underlying disease 3. Age 55 years or older 4. Patient who refused intravenous chemotherapy 5. Informed patient

Exclusion criteria

Exclusion criteria: 1. Patient who can not come to follow up until end of the study 2. Patients with one of the following conditions (screening from medical documents) Congestive heart failure Decompensated cirrhosis Chronic kidney disease stage 3-4 COPD, mod-severe AIDS

Design outcomes

Primary

MeasureTime frame
survival rate death day

Secondary

MeasureTime frame
grade 3-4 toxicity and adverse events at visit case record form

Countries

Thailand

Contacts

Public ContactSaranya Pongudom

medicine department, Udonthani hospital

jangth172@gmail.com0817174129

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026