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Circulating tumor DNA for minimal residual disease in acute myeloid leukemia after allogeneic hematopoietic stem cell transplant: a multi-center prospective study.

Circulating tumor DNA for minimal residual disease in acute myeloid leukemia after allogeneic hematopoietic stem cell transplant: a multi-center prospective study. - ctDNA for MRD with AML after transplant.KSGCT1702(ctDNA)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000033003
Enrollment
70
Registered
2018-06-15
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndromes

Interventions

None listed

Sponsors

Kanto Study Group for Cell Therapy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Any patient (age >= 20 yo and =< 65 yo) with acute myelogenous leukemia (except for acute promyelocytic leukemia) or myelodysplastic syndromes by WHO2008 criteria 2. Any patient with any disease status or any history/sensitivity of chemotherapy at allogeneic stem cell transplant 3. Patient must have adequate tumor samples at diagnosis or relapse available for analyses (tumor proportion more than 20%) 4. Any patient who have no history of allogeneic stem cell transplant, for whom an myeloablative allogeneic stem cell transplant is warranted 5. Any patient who have signed informed consent available with regard to this study

Exclusion criteria

Exclusion criteria: 1. Any patient who decline to register 2. Any patient who are considered as inappropriate to register by attending physician

Design outcomes

Primary

MeasureTime frame
To evaluate 1-year cumulative incidence of relapse rate according to circulating tumor DNA status post allogeneic hematopoietic stem cell transplant

Secondary

MeasureTime frame
1. To evaluate 1-year overall survival rate according to circulating tumor DNA status post allogeneic hematopoietic stem cell transplant 2. To compare the utility of circulating tumor DNA status and conventional biomarkers 3. To compare the profiles of the somatic mutation, gene expression, and immunological cell status between diagnostic and relapsed samples from bone marrow or peripheral blood

Countries

Japan

Contacts

Public ContactKazuaki Yokoyama

Research Hospital, The Institute of Medical Science, The University of Tokyo Department of Hematology/Oncology

ksgctdc@ksgct.net03-3443-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026