Acute myeloid leukemia(AML) Acute lymphoblastic leukemia(ALL) Acute leukemias of ambiguous lineage Myelodysplastic syndrome(MDS) Chronic myeloid leukemia(CML) Adult T-cell leukemia/lymphoma(ATLL) Malignant lymphoma(ML)
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), and melphalan (100 mg/
Sponsors
Osaka City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among patients with refractory hematological disorders (indicated in the selection criteria) who are clinically adopted to allo-HSCT because they cannot expect to be cured or long-term survival by any other therapy, patients who do not have or not available HLA serological identical related donors and have HLA-haploidentical donors. 1) Age >= 15 and < 70 years old 2) ECOG PS 0 or 1 3) Normal function of major organs 4) Informed consent has been acquired 5)Indication (a) AML 1. Refractory to 1st induction therapy 2. Relapse after chemotherapy 3. 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 4. Normal karyotype and FLT3-ITD mutation 5. Intermediate/poor group by JALSG score 6. AML with MRC 7. History of relapse after allo-HSCT 8. CR1 with standard risk or high risk (b) ALL 1. Refractory to 1st induction therapy 2. Relapse after chemotherapy 3. Any of 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 4. History of relapse after allo-HSCT (c) Acute leukemias of ambiguous lineage 1. Refractory to the first induction therapy 2. Relapse after chemotherapy 3. Unfavorable chromosome abnormality 4. History of relapse after allo-HSCT (d) MDS 1. RAEB-1 or 2 2. IPSS intermediate-2 or high 3. Transfusion dependent 4. History of relapse after allo-HSCT (e) CML 1. AP or BC: refractory to multiple TKIs 2. CP beyond 1st CP or AP 3. History of relapse after allo-HSCT (f) ATLL, ML 1. ATLL Acute or lymphoma type in the PR or better 2. ML Malignant lymphoma which is classified in the 2008 WHO classification which relapse after auto-HSCT, or which have no indication for auto-HSCT due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy
Exclusion criteria
Exclusion criteria: 1) Major organ dysfunction a) Total bilirubin: >= 2.0 mg/dl b) Serum creatinine: >= 2.0 mg/dl c) Left ventricular 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 woman or woman of childbearing potential 8) Patients with a severe mental disorder 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) A history of administration of mogamulizumab 12) 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 fo1lowing transplantation | — |
Countries
Japan
Contacts
Public ContactHirohisa Nakamae
Osaka City University, Graduate School of Medicine Hematology
Outcome results
None listed