Hematological malignancy
Conditions
Interventions
1) Allogenic stem cell transplantation from HLA-haploidentical related donor
2) GVHD prophylaxis: Cyclophosphamide (50 mg/kg) is given on day 3, 4 after the graft infusion. Continuous intravenous tacr
Sponsors
Nakamae Hirohisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among patients with hematological malignancy (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 >= 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 4. History of relapse after allo-HSCT 5.History of relapse after CAR-T therapy (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. EB-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 WHO classification (revised 4th edition) which relapse after auto-HSCT or CAR-T therapy due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy (g) Other, among hematological malignancies, the disease which is approved as an indication of allo-HSCT in our conference
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) 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.The positivity of 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 |
|---|---|
| Comparison of progression free survival between the two groups divided by the donor scoring points | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival, event-free survival 2) Non-relapse mortality 3) Relapse/progression 4) Cumulative incidence of grade II to IV and III to IV acute GVHD 5) Cumulative incidence of chronic GVHD 6) GVHD-free relapse free survival (GRFS) 7) Immunosuppressant discontinuation rate 8) Neutrophil and platelet engraftment 9) Regimen related toxicity 10) Non-infections fever within 7 days after transplantation 11) Immune reconstitution 12) Subgroup analysis of the above endpoints stratified by donor relationship to patient, HLA incompatibility locus/number, direction, presence of KIR R-L mismatch, KIR haplotype, and presence of donor B/x with 2DS2 13) Subgroup analysis according to stem cell count 14) Subgroup analysis according to primary disease and disease risk index 15) Exploratory analysis of other factors for prediction of transplant prognosis | — |
Contacts
Public ContactHirohisa Nakamae
Osaka Metropolitan University Graduate School of Medicine
Outcome results
None listed