AML-SCT15
- Conditions
- acute myeloid leukemia (AML)
- Registration Number
- JPRN-jRCTs051180190
- Lead Sponsor
- YABE Hiromasa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
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
6)Written informed consent has been acquired from patients and/or persons with parental authority.
7)Cases in which a suitable donor is available and hematopoietic cell transplantation is considered to be mandatory
8)Patients whose performance status are 0 or 2 by ECOG criteria
9)Patients who satisfactory meet all of the following criteria about organ functions within 28 days prior to registration
a)Patients without uncontrolled cardiac failure and ejection fraction of left ventricle >= 50% by UCG
b)%VC >= 50% and FEV1.0% >= 50%, or SpO2 >= 95% by room air if pulmonary function tests are impossible
c)AST/ALT < 5 x upper limit of normal range (CTCAE < grade 2)
d)Patients without uncontrolled renal failure and sCr < 2 x upper limit of normal range
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probability of overall survival rate at three years after transplantation
- Secondary Outcome Measures
Name Time Method