Patients with hematological disease scheduled to undergo first hematopoietic stem cell transplantation.
Conditions
Interventions
Patients receive intravenous cyclosporine (3mg/kg/day) from day -1. Patients receive oral mycophenolate mofetil 1500mg/day from 6h after completion of hematopoietic stem cell transplantation.
Sponsors
Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hematological disease who are scheduled to undergo first stem cell transplantation and who have a 6/6 HLA antigen-matched related donor ATG use as part of conditioning regimen is not permitted. Eligible diseases; (a)AML 1. First CR with high or intermediate risk 2. Second CR or greater 3. Relapse or failure to achieve CR after the first course of induction chemotherapy (b)ALL 1. First CR 2. Second CR or greater 3. Relapse or failure to achieve CR after the first course of induction chemotherapy (c)Acute leukemias of ambiguous lineage 1. First CR 2. Second CR or greater 3. Relapse or failure to achieve CR after the first course of induction chemotherapy (d)MDS 1. Patients with poor prognosis who have IPSS scores of int-2 or high 2. Transfusion dependence requiring RBC transfusion over 2 units per week or platelet transfusion over 10 units per week (e)CML 1. Second CP or greater 2. AP 3. First CP or tyrosine kinase inhibitor failure (f)Malignant lymphoma 1. Indolent lymphoma First relapse or greater /progression, regardless of sensitivity to prior chemotherapy 2. Agressive lymphoma First relapse which are not sensitive to chemotherapy Patients in second or greater relapse or relapse after autologous stem cell transplantation who are not likely to relapse or progress within 3 month after transplantation *ECOG performance status score:0 or 1 *Normal function of major organ *Signed informed consent *A life expectancy beyond 3 months
Exclusion criteria
Exclusion criteria: (1)Major organ dysfunction(non-myeloablative SCT): (a)Ejection fraction: <40% (b)Pulmonary function test: %VC<30%, FEV1.0% <40%, or SaO2 <90% on room air (c)Serum creatinine: >2.0mg/dl (d)Liver function: total bilirubin >2.0mg/dl, AST or ALT >3 x UNL, or patients with chronic active hepatitis or liver cirrhosis (2)Poorly controlled hypertension (3)HIV antibody positivity (4)Uncontrolled active infection (5)Uncontrolled CNS invasion (6)Pregnant, nursing or possibly pregnant woman (7)Patients with severe mental disorder who are likely unable to participate in the study (8)Known hypersensitivity or allergy to any of the drugs in the conditioning regimen of this transplant, or drugs used for GVHD prophylaxis (9)No indication for this study as judged by physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade II to IV aGVHD before day100 post-transplantation | — |
Countries
Japan
Contacts
Public ContactMasaaki Kurihara
Japanese Clinical Research Support Unit Data center
Outcome results
None listed