Hematologic malignancies with an indication for allogeneic hematopoietic stem cell transplantation (allo- HSCT) Acute myeloid leukemia Myelodysplastic syndrome Chronic myeloid leukemia Malignant lymphoma Acute lymphoblastic leukemia
Conditions
Interventions
For conditioning fludarabine 30 mg/square meter for 6 days and melphalan 70mg/square meter for 2 days, and ATG 2.5mg/kg for 3 days are used. GVHD prophylaxis consists of continuous intravenous tacro
s weight)
Sponsors
Hematology, Osaka City University, Graduate School of Meicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hematologic malignancies which are incurable by only conventional chemotherapy, and therefore has an indication for allogeneic hematopoietic stem cell transplantation. Eligible diseases; (a)AML 1. First CR with high risk 2. Second CR or greater 3. Relapse or failure to achieve CR after the first course of induction chemotherapy (b)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 (c)CML 1. Second CP or greater 2. First CP or tyrosine kinase inhibitor failure (d)Malignant lymphoma 1. Indolent lymphoma First relapse or greater /progression, regardless of sensitivity to prior chemotherapy 2. Agressive lymphoma *First relapse or greater /progression *Clinical response to prior chemotherapy : PR or CR (e)ALL 1. CR (2) Patients lacking a 6/6 or 5/6 HLA antigen-matched related donor (3) Patients lacking an HLA-identical unrelated donor, or patients who require urgent transplantation due to disease status but can hardly receive transplantation from unrelated HLA-matched donor in a timely fashion (4) ECOG performance status score:0-2 (5) Patients with no indication for myeloablative conditioning (6) Signed informed consent Donor eligibility criteria: (1) CB unit preserved in the Japanese cord blood bank (2) HLA-A, B, DR 8/8 allele match or mismatch at one or two alleles. (3) >= 2.5 X 10^7 total nucleated cell /kg (Patient's weight)
Exclusion criteria
Exclusion criteria: (1)Major organ dysfunction: (a)Ejection fraction: <30% (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)Patients with positive donor-specific HLA antibodies(DSA) (10)Patients with graft failure following allegeneic hematopoietic stem cell transplantation (11)No indication for this study as judged by physician in charge. Note: HBs antigen positivity and HCV antibody positivity is not excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 60 survival rate of patients who achieved engraftment after transplantation | — |
Countries
Japan
Contacts
Public ContactMika Nakamae
Osaka City University, Graduate School of Medicine Hematology(Clinical reserch center for hematological malignancies )
Outcome results
None listed