Acute myeloid leukemia(AML) Acute lymphoblastic leukemia (ALL) Secondary acute myelogenous leukemia Chronic myeloid leukemia (CML) Myelodysplastic syndrome (MDS)
Conditions
Interventions
Fludarabine(15mg/square meter of body surface area twice a day for 2 days and 30mg/square meter once a day for 4 days), cytarabine(2g/square meter twice a day for 2 days), buslufan(0.8mg/kg 4 times a
Sponsors
Hematology, Osaka City University, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with refractory leukemia or MDS lacking an HLA-identical or single-antigen mismatched related donor, who need an urgent allogeneic transplant but are ineligible for unrelated donor from marrow donor registry in a timely fashion due to rapid disease progression, or patients with refractory leukemia or MDS considered incurable by only conventional chemotherapy, who have no HLA-identical related or HLA-single-antigen mismatched related donor. 2) Patients without a HLA-haploidentical donor of family member or relative 3) >= 15 and <= 70 years old 4) ECOG PS 0-1 5) Normal function of major organ 6) Informed consent 7) Patients who in need of an urgent allogeneic transplant a) De novo AML and ALL: refractory to first induction therapy or refractory to chemotherapy after relapse b) CML in AP or BC: refractory to TKIs including imatinib, dasatinib and nilotinib c) Secondary acute leukemia following MDS: refractory to first induction therapy d) Patients with AML, ALL, CML or secondary acute leukemia who relapsed after allogeneic transplant and failed to achieve CR 8) Patients who have indication for allogeneic transplant due to unfavorable prognosis but lack a suitable related donor a) Patients with de novo AML in CR with unfavorable chromosome abnormality including del(5q)/-5, -7/del(7q), abn 3q, 9q, 11q, 20q, 21q, 17q, t(6;9), t(9;22) or complex karyotype b) Patients with de novo AML in CR with normal karyotype and FLT3-ITD mutation c) Patients with ALL in 1CR who have following poor prognostic factors i) t(9;22) or t(4;11) ii) >= 35 years at diagnosis iii) WBC count of more than 30000/uL for B- ALL, or more than 100000/uL for T-ALL at diagnosis d) AML, ALL in CR state except for 1CR e) CML in CR state except for 1CR f) Secondary leukemia following MDS, or patients with RAEB-1, 2 g) Patients with AML, ALL, or secondary leukemia in CR state or CML in CP who 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 3 months, liver cirrhosis and interstitial pneumonia 7) Pregnant, nursing or possible fertile woman 8) Patients with severe mental disorder who are likely to unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplant 10) HIV antibody positivity 11) No indication for this study judged by physician in charge. (Note: HBs antigen positivity and HCV antibody positivity is not excluded.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Engraftment rate | — |
Countries
Japan
Contacts
Public ContactMika Nakamae
Osaka City University, Graduate School of Medicine Hematology
Outcome results
None listed