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Phase II clinical trials aiming to establish standard therapy by chemotherapy for transient myelodysplastic syndrome (TAM)

Phase II clinical trials aiming to establish standard therapy by chemotherapy for transient myelodysplastic syndrome (TAM) - TAM-18

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041190063
Enrollment
250
Registered
2019-08-28
Start date
2019-09-30
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Transient abnormal myelopoiesis Leukemia, Transient, Down syndrome

Interventions

Those who meet the following criteria will be administered a cytarabine therapy. 1) White blood cell count is 100,000 /micro L or more 2) Self-urine at the start of treatment (1 ml/kg/h) or more is ob
cytarabine

Sponsors

Muramatsu Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Those that meet all the following criteria shall be eligible. (1) Blast cells appeared in peripheral blood less than 30 days of age, and diagnosed as TAM. (2) Registration is within 30 days from the diagnosis date. (3) Written consent was obtained from the substitute.

Exclusion criteria

Exclusion criteria: Not particularly provided.

Design outcomes

Primary

MeasureTime frame
1 year overall survival of patients who received low dose cytarabine therapy.

Secondary

MeasureTime frame
1 year overall survival rate of total cohort. 2 year/4 year overall survival rate of total cohort and low dose cytarabine treatment group Positive rates of minimal residual disease (MRD) at 1 month /3 months /6 months /12 months /18 months /24 months in overall and low dose cytarabine treatment group 2 years /4 years cumulative incidence of leukemia in total cohort and low dose cytarabine treatment group Cumulative incidence of leukemia in MRD (GATA1-MRD/FCM-MRD) positive patients and negative patients in total cohort and low dose cytarabine treatment group Adverse events of low-dose cytarabine treatment group Early death (within 9 months of birth) and cumulative incidence of leukemia among GATA1 gene mutation types in total cohort and low dose cytarabine treatment group

Contacts

Public ContactHideki Muramatsu

Nagoya University Hospital

hideki-muramatsu@med.nagoya-u.ac.jp+81-52-744-2294

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 7, 2026