Acute myeloid leukemia(AML) Acute lymphoblastic leukemia (ALL) Chronic myeloid leukemia (CML) Myelodysplastic syndrome (MDS)
Conditions
Interventions
Fludarabine (15 mg/square meter of body surface area twice a day for 2 days and 30 mg/square meter once a day for 4 days), cytarabine (2 g/square meter twice a day for 2 days), Melphalan (100mg/ squa
Sponsors
Osaka City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with poor-prognosis or refractory leukemia or MDS who lack an HLA serological identical related donor. 2) Patients who have an HLA -haploidentical donor of family member or relative 3) Age >=15 and < 70 years old 4) ECOG PS 0 or 1 5) Normal function of major organs 6) Informed consent has been acquired. 7) Patients who are in need of a prompt allogeneic transplant a) De novo AML: refractory to first induction therapy or relapse after chemotherapy b) ALL: refractory to first induction therapy or relapse after chemotherapy c) CML in AP or BC: refractory to TKIs including imatinib, dasatinib and nilotinib d) Patients with AML, ALL, CML or MDS who have relapsed after allogeneic transplant 8) Patients who have an indication for allogeneic transplantation due to an unfavorable prognosis but lack a suitable related donor a) Patients with de novo AML in the CR with an unfavorable chromosome abnormality including del(5q)/-5,- 7/del(7q), abn 3q, 9q, 11q, 20q, 21q, 17q, t(6;9), t(9;22) or a complex karyotype b) Patients with de novo AML in the CR with normal karyotype and FLT3-ITD mutation c) Patients with AML with intermediate/poor group by JALSG score d) Patients with ALL in 1CR who have the following poor prognostic factors i) t(9;22) or t(4;11) ii) >=35 years of age at diagnosis iii) WBC count of more than 30,000/uL for B- ALL, or more than 100,000/uL for T-ALL at diagnosis e) AML, ALL in the CR state except for 1CR f) CML in the CR state except for 1CR g) MDS with RAEB-1, 2, AML with MRC h) Patients with AML, ALL, or CML in CP who have relapsed after allogeneic transplant
Exclusion criteria
Exclusion criteria: 1) Major organ dysfunction a) Total bilirubin:>= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: < 50 % d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air e) AST or ALT >= 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia 7) Pregnant, lactating or possible fertile women who may become pregnant 8) Patients with a severe mental who are likely to be unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant 10) HIV antibody positivity 11) The physician in charge determines that there is no indication to perform this intervention. (Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who survive with graft engraftment at 100 days following transplantation | — |
Countries
Japan
Contacts
Public ContactHirohisa Nakamae
Graduate School of Medicine, Osaka City University Hematology
Outcome results
None listed