acute myeloid leukemia, acute lymphoid leukemia, chronic myeloid leukemia, chronic lymphoid leukemia, myelodysplastic syndrome, malignant lymphoma, multiple myeloma, myeloproliferative disorder, severe aplastic anemia
Conditions
Interventions
Haploidentical transplantation using frozen grafts
Haploidentical transplantation using non-frozen grafts
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Disease status 1. Acute myeloid leukemia: second complete remission or later complete remission, induction failure. non-remission status 2. Acute lymphoid leukemia:second complete remission or later complete remission, induction failure. non-remission status, MRD-positive first complete remission in Philadelphia(+) leukemia 3. Myelodysplastic syndrome and myelodysplastic proliferative disorder: intermediate-II or high in International Prognostic Factor Scoring System 4. Malignant lymphoma: patients have to meet the following 2 requirements 1) Histology: the following histology has to be confirmed. a. precursor B- and T-cell neoplasms: precursor B-lymphoblastic lymphoma, precursor T cell lymphoblastic lymphoma b. mature B-cell neoplasms: mantle cell lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, Burkitt lymphoma, intravascular large B-cell lymphoma c. mature T-cell and NK-cell neoplasms: adult T-cell leukemia/lymphoma, extranodal NK/T-cell lymphoma, enteropathy-type T-cell lymphoma, blastic NK-cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheripheral T-cell lymphoma (unspecified) d. Hodgkin's lymphoma 2) Disease status: a. Induction failure b. Complete or partial remission is not achieved in salvage chemotherapy c. Second relapse or later stage B. Donor: patients have to meet the following 3 requirements 1. Patients have no related HLA-matched or 1 antigen-mismatched donors 2. Patients have no HLA-matched unrelated donors or HLA-1 locus mismatched donors in allele type, or urgently need transplantation. 3. Patients have HLA 2-3 antigen-mismatched (in GVH direction) donors.
Exclusion criteria
Exclusion criteria: 1. ECOG performance status scale: 3-5 2. Cardiac dysfunction: ejection fraction < 50% 3. Oxygen saturation < 93% 4. Hepatic dysfunction: Total bilirubin > 2.0 mg/dl or AST > 2.5 times the normal upper limit 5. Renal dysfunction: serum creatinine level > 1.5 times the normal upper limit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose of steroids on day 100 | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of severity of acute GVHD, hematopoietic recovery, engraftment rate, tapering speed of steroids, the incidence of severity of chronic GVHD, survival rate at 1 year, disease-free survival at 1 year, therapy-related mortality at 1 year, the incidence of infection (bacterial, fungal, virus), relapse rate at 2 years, the probability of discontinuation of steroids or immunosuppressants | — |
Countries
Japan
Contacts
Public ContactHiroyasu Ogawa
Hyogo College of Medicine Division of Hematology, Department of Internal Medicin
Outcome results
None listed