acute myeloid leukemia, acute lymphoid leukemia/first or second allogeneic stem cell transplantation
Conditions
Interventions
Patients with AML or ALL at poor risk undergo transplantation using peripheral blood stem cells from an HLA-haploidsentical donor. The conditioning treatment consists of fludarabine 30 mg/m2/day x 6 (
20%, cytarabine 2 g/m2/day x 4 (days -9 to -6) is added. Peripheral blood stem cells containing 3.0-10.0 CD34 cells/kg (patients'
body weight) is infused on day 0. GVHD prophylaxis consists of tacrolimus and methylprednisolone 1 mg/kg. Tacrolimus and methylprednisolone are started on day -2 and 0, respectively.
Sponsors
Hyogo College of Medicine
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Saiseikai Maebashi Hospital, Japanese Red Cross Nagoya First Hospital, Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A related donor who is matched or 1 antigen-mismatched in HLA-A, -B, and -DR antigen is not available. 2. An unrelated donor who is matched in HLA-A, -B, -DR antigen, and allelic mismatched 0 or 1 locus in HLA-A, -B, -DR loci is not available. When patients is an urgent situation, those are eligible. 3. A related HLA-haploidentical donor is available. 4. Disease status; for AML, any status other than first CR is eligible. Patients with AML in first CR with poor karyotype, MRD positivity, FLT-ITD mutation(+), M0, and induction failure after first induction therapy are eligible. For ALL, patients in any status is eligible. 5. Patients who undergo first or second allogeneic stem cell transplantation are eligible. 6. Performance status is 0 or 1 in ECOG criteria. 7. Patients do not have an organ failure, including heart, lung, liver, and kidney, as follows: 1) Ejection friction >50%, 2) SO2>93%, 3) T bilirubin <2.0 mg/dl and AST <2.5 times the normal upper limit, 4) serum creatinine level <1.5 times the normal upper limit.
Exclusion criteria
Exclusion criteria: 1. A history of adverse events for agents used in the conditioning treatment or GVHD prophylaxis. 2. Active CNS disorders other than leukemia. 3. Active infection. 4. Doctor's decision that patients are inappropriate for this study in some reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a prospective, multi-center (5 transplant centers) study of HLA-haplidentical stem cell transplantation. A hundred patients are planning to be enrolled. The major outcome is survival on day 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incidence and severity of acute GVHD 2. The incidence and severity of chronic GVHD 3. Survival rate at 1 year 4. Disease-free survival rate at 1 year 5. transplant-related mortality at 1 year 6. The incidence of infection (bacterial, fungus, virus, others) 7. Immunological recovery 8. Iron overload 9. The concentration of ATG on days 0 and 7. 10. donor T cell repertoire analysis | — |
Countries
Japan
Contacts
Public ContactHiroyasu Ogawa
Hyogo College of Medicine Division of Hematology, Department of Internal Medicine
Outcome results
None listed