Acute myeloid leukemia Acute lymphoblastic leukemia Adult T cell leukemia Chronic myelogenous leukemia Myelodysplastic syndrome Non-Hodgkin lymphoma Hodgkin lymphoma
Conditions
Interventions
Conventional GVHD prophylaxis (non ATG group) Tacrolimus is started on day -1 at a dose of 0.02 - 0.03 mg/kg per day by continuous infusion, and the dose is adjusted to maintain a blood concentration
Sponsors
Clinical research committee of the Japan Society for Hematopoietic Cell Transplantation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have one of the following disease statuses (a) AML: any stages with <=50% of blasts in BM and PB (b) ALL: any stages with <=50% of blasts in BM and PB (c) ATL: any stages with <=50% of malignant cells in BM and PB (d) CML: stages with either >=CP2, AP, BP, or failure to 2 types of TKIs, with <=50% of blasts in BM and PB (e) MDS: IPSS, intermediate-II or high;IPSS-R, intermediate, high or very high; WPSS, intermediate-II or high; relapse after remission (f) NHL: patients who have one of the following statuses (1)low-grade lymphoma: chemo-refractory, relapse after autologous SCT, CR or PR after >=3 lines of chemotherapy (2) intermediate-grade lymphoma: PR,>=CR2 (3) high-grade lymphoma: PR, CR (g) Hodgkin lymphoma: PR, >=CR2 2. Patients who are 16 to 65 years old 3. Patients who do not have an available HLA-A, -B, -DR matched related donor 4. Patients who do not have an HLA-A, -B, -C, -DRB1 8/8 allele matched unrelated donor candidate, or it takes long time for donor coordination because of lack of allele information, etc, despite many HLA-A, -B, -DR antigen matched donor candidates. 5. Patients who have an unrelated bone marrow donor with an HLA-1 locus mismatch at HLA-A, -B, -C, and -DRB1 locus. 6. Donors who are 20 to 55 years old 7. Patients with ECOG performance status of 0, 1, or 2 8. Patients whose major organ functions (heart, lung, liver, kidney) are preserved and who meet all of the following criteria (a) Ejection fraction>=40% (b) SaO2>=94% on room air or SpO2>=94% on room air (c) Pulmonary function test: %VC>=70%, FEV1.0%>=70% (d) Serum total bilirubin <=2.0 mg/dl and serum AST<=5 x UNL (e) Ccr >=30ml/min
Exclusion criteria
Exclusion criteria: 1. Presence of donor-specific HLA antibodies 2. Patients with HBs antibody positive 3. Patients with HIV antibody positive 4. Patients with serious mental disorder who are likely unable to participate in the study 5. Patients who are pregnant, nursing, or possibly pregnant 6. Patients with coexistence of malignancy 7. Patients with poorly controlled active infection 8. Patients who are allergic to ATG 9. Prior history of allogeneic hematopoietic cell transplantation within 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate at 1 year after transplantation (Success is defined as the situation without the following events within 1 year after transplantation 1. Death 2. Relapse 3. Grades III-IV acute GVHD 4. Severe chronic GVHD or mild chronic GVHD requiring systemic steroid treatment) | — |
Countries
Japan
Contacts
Public ContactJunya Kanda
Kyoto University Hospital Department of Hematology and Oncology
Outcome results
None listed