Hematologic malignancies with an indication for allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
Conditioning regimen with fludarabine 25mg/m2 for 5 days, melphalan 40mg/m2 for 2 days and TBI at a dose of 2 Gy on day-1 are used. GVHD prophylaxis consists of tacrolimus given at 0.03mg/kg/day as c
Sponsors
Hematology, Osaka City University, Graduate School of Meicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with hematologic malignancies who are incurable by conventional treatments and therefore have an indication for allo-HSCT Eligible diseases; (a)AML 1. First CR with high risk 2. Second CR or greater 3. Relapse or failure to achieve CR by the first induction chemotherapy (b)MDS 1. Poor prognosis MDS with IPSS scores of int-2 or higher 2. Patinets with transfusion-dependent MDS who require 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 (including CLL) First relapse/progression,or greater, regardless of sensitivity to prior chemotherapy (e)ALL (including Ph positive ALL) 1. CR (2) Patients lacking a 5/6 or 6/6 HLA-A/B/DR serologically matched related donor (3) Patients lacking an HLA-A/B/DR serologically matched unrelated donor, 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 who are not candidates for myeloablative transplantation (6) Written informed consent before participation
Exclusion criteria
Exclusion criteria: (1)Patients who have any major organ dysfunction as follow (a) Heart: Ejection fraction <30% at rest (b) Lung: %VC<30% or FEV1.0%<40% or PaO2<60mmHg(SpO2<90%) on room air (c) Kidney: serum creatinine level >2.0 mg/dl (d) Liver: total bilirubin level >2.0 mg/dl or ALT>3.0 x ULN (upper limit of normal) or chronic active hepatitis or cirrhosis (2) Poorly controlled hypertention (3) Positivity for HIV antibody (4) Uncontrolled active infections (5) Uncontrolled central nervous system involvement (6) Pregnant, nursing or possibly pregnant woman (7) Patients with mental disorder who are considered difficult to participate in the study (8) Known hypersensitivity to any of the drugs in the conditioning regimen or drugs used for GVHD prophylaxis (9) Patients with positive donor-specific HLA antibodies(DSA) (10) Engraftment failure after allogeneic hematopoietic stem cell transplantation (11) Inappropriate to participate in this study as judged by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 60 survival rate of patients with successful engraftment after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Overall survival and progression free survival at day 100 (2) Non-relapse mortality at day 100 (3) Rate of primary graft failure, secondary graft failure (4) Time to hematopoietic recovery and achievement of complete donor T-cell chimerism (5) Incidence and severity of acute GVHD and chronic GVHD (6) Regimen-related toxicity (7) Rate of relapse (8) Incidence of bacterial, fungal and viral infection (9) Immune reconstitution after transplantation | — |
Countries
Japan
Contacts
Public ContactMika Nakamae
Osaka City University, Graduate School of Medicine Hematology(Clinical research center for hematological malignancies )
Outcome results
None listed