JPRN-jRCTs051180190
Recruiting
Phase 2
Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15). - AML-SCT15
YABE Hiromasa0 sites66 target enrollmentMarch 26, 2019
Conditionsacute myeloid leukemia (AML)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- acute myeloid leukemia (AML)
- Sponsor
- YABE Hiromasa
- Enrollment
- 66
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •1\)AML (acute promyelocytic leukemia, AML which developed in patients with Down syndrome, secondary AML, AML which developed in patients with myelodysplastic syndrome, NK/myeloid leukemia and granulocytic leukemia are excluded)
- •2\)Cases registered in the prospective study in JPLSG (JPLSG CHM\-14\)
- •3\)Patients with high\-risk AML in first complete remission or bone marrow\-relapsed patients with AML in second complete remission
- •4\)High\-risk AML
- •Any of the following
- •a)Unfavorable chromosome abnormality including \-7, del(5q)/\-5, t(16;21\)(p11;q22\)/FUS\-ERG, t(9;22\)(q34;q11\.2\)/BCR\-ABL1 or t(6;11\)(q27;q23\)/MLL\-MLLT4(AF6\), or unfavorable genetic abnormality including FLT3\-ITD or NUP98\-NSD1
- •b)Blast ratio \>\=5% in the bone marrow (M2/M3 marrow) after the first induction therapy
- •c)Extramedullary lesions after the first induction therapy
- •5\)Patients less than 18 years at the initial diagnosis in first remission, or patients less than 20 years at the relapse diagnosis in second remission
Exclusion Criteria
- •Exclusion criteria
- •1\)Patients who have extramedullary lesions at registry
- •2\)Patients who have prior radiation therapy
- •3\)Patients who have prior hematopoietic cell transplantation
- •4\)Patients who have poorly controlled infectious disease
- •5\)Patients who have psychiatric disorder
- •6\)Patients who have coinciding malignancies
- •7\)Patients who have an episode of hypersensitivity reactions against drugs used in conditioning regimens and/or GVHD prophylaxis
- •8\)Pregnant women or women who may be pregnant
- •9\)Patients who are considered as inappropriate for this trial by attending physicians
Outcomes
Primary Outcomes
Not specified
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