Study to assess the Effects of Gilteritinib Maintenance Therapy on Leukemia and Normal Immune Cells after Allogeneic Hematopoietic Stem Cell Transplantation

Study on the Effects of Gilteritinib Maintenance Therapy on Leukemia and Normal Immune Cells after Allogeneic Hematopoietic Stem Cell Transplantation - The Effects of Gilteritinib Maintenance Therapy after allo-HSCT for AML

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055182

Enrollment

Registered

2024-08-07

Start date

2024-02-02

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Cases aged 18 years or older at the time of informed consent 2. Cases of refractory AML who underwent allogeneic hematopoietic stem cell transplantation between the study approval date and March 31, 2026 3. Cases with a Performance Status (ECOG) of 0 to 2 4. Cases with an expected survival of three months or more 5. Cases without severe organ dysfunction 6. Cases for which written informed consent has been obtained from the patient after explaining the study details 7. Cases for which written informed consent has been obtained from the patient regarding participation in the preceding study KCNET

Exclusion criteria

Exclusion criteria: 1. Cases with active overlapping cancers 2. Cases with uncontrolled infections 3. Cases with severe psychiatric disorders 4. Cases who are pregnant or currently breastfeeding 5. Cases deemed inappropriate by the attending physician for other reasons

Design outcomes

Primary

Measure	Time frame
Evaluation of the Dynamics of AML and Immune Cells	—

Secondary

Measure	Time frame
1. Measurement of minimal residual disease (MRD) by multicolor flow cytometry 2. Incidence of acute and chronic GVHD 3. Relapse rate after allogeneic transplantation 4. Non-relapse mortality rate after allogeneic transplantation 5. Disease-free survival rate after allogeneic transplantation 6. Overall survival rate after allogeneic transplantation 7. Duration of complete remission after allogeneic transplantation	—

Measure

Time frame

1. Measurement of minimal residual disease (MRD) by multicolor flow cytometry 2. Incidence of acute and chronic GVHD 3. Relapse rate after allogeneic transplantation 4. Non-relapse mortality rate after allogeneic transplantation 5. Disease-free survival rate after allogeneic transplantation 6. Overall survival rate after allogeneic transplantation 7. Duration of complete remission after allogeneic transplantation

—

Countries

Japan

Contacts

Public ContactTakuji Yamauchi

Kyushu University Hospital Department of Hematology, Oncology and Cardiovascular Medicine

yamauchi.takuji.355@m.kyushu-u.ac.jp092-642-5230

Outcome results