Hematologic malignancy
Conditions
Interventions
1) Allogenic hematopoietic cell transplantation from a HLA 1 or 2 allele-mismatched unrelated donor
2) GVHD prophylaxis: Cyclophosphamide (50 mg/kg) is given on day 3, 4 after the graft infusion. Co
n
Sponsors
Kuno Masatomo
Nakamae Hirohisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meet all of the following criteria (1-6) : 1) Age >= 16 and = 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 History of relapse after allo-HSCT History of relapse after CAR-T therapy (c) Acute leukemias of ambiguous lineage Refractory to the first induction therapy Relapse after chemotherapy Unfavorable chromosome abnormality History of relapse after allo-HSCT (d) MDS EB-1 or 2 IPSS intermediate-2 or high Transfusion dependent History of relapse after allo-HSCT (e) CML AP or BC: refractory to multiple TKIs CP beyond 1st CP or AP History of relapse after allo-HSCT (f) ATLL Acute or lymphoma type in the SD or better (g) ML Malignant lymphoma which is classified in the WHO classification (revised 4th edition) which relapse after auto-HCT or CAR-T therapy, or which have no indication for auto-HCT or CAR-T therapy due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy (h) The disease which is approved as an indication of allo-HSCT in our conference 5) Patients who have a HLA 1-2 allele-mismatched unrelated donor and have no HLA matched relate d or unrelated donor 6) Informed consent has been acquired
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: = 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 uncontrolled 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) HIV antibody positivity 10) A history of hypersensitivity or allergy to cyclophosphamide, tacrolimus or mycophenolate mofetil 11) Plan for administration of ATG for conditining or GVHD prophylaxis 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. The positivity o f donor-specific antigen (DSA) is not excluded but DSA with MFI >=5000 should be avoided as much as possible.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade III-IV acute GVHD-free survival at day 100 after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Cumulative incidence of acute and chronic GVHD at 100 days and 1 year 2) Non-relapse mortality at 100 days and 1 year 3) Relapse/progiression at 100 days and 1 year 4) Overall survival and progression free survival at 100 days and 1 year 5) GVHD-free relapse free survival at 100 days and 1 year 6) Regimen related toxicity within 100 days after transplantation 7) Non-infections fever within 7 days after transplantation 8) Neutrophil and platelet engraftment and primary or secondary graft failure within 100 days and 1 year after transplantation 9) Infectious events within 100 days and 1 year after transplantation 10) The proportion of patients who stopped immunosuppressive drugs within 1 year after transplantation 11) Immune reconstitution using multi-color flowcytometer 12) Subgroup analysis according to stem cell source (BM or PB) 13) Subgroup analysis according to HLA disparity 14) Subgroup analysis according to stem cell count 15) Subgroup analysis according to primary disease and disease risk index | — |
Contacts
Public ContactMasatomo Kuno
Osaka Metropolitan University, Graduate School of Medicine
Outcome results
None listed