Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Multiple myeloma
Conditions
Interventions
Reduced-intensity conditioning followed byintra-bone-marrow cord blood transplantation
Sponsors
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following are required. (1)Adult patients with hematological malignancy who need allogeneic transplantation (2)Any of the following is required. 1.Age 55 or older 2.Patients with Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) of one or more between 16 and 55 years old 3.A prior history of hematopoietic stem cell transplantation (3)No suitable donor is available except unrelated cord blood. (4)Marrow blasts less than 70% (5)Written informed consent to participate the trial. (6)Performance status(ECOG) 0 or 1 (7)A cord blood unit matched at >4 of 6 HLA antigens (A, B, DR) and with cryopreserved total nucleated cell dose of >2 x 10E7/kg is available.
Exclusion criteria
Exclusion criteria: Any of the following. (1)Positive for HIV antibody or HBs antigen or HCV antibody (2)Patients treated with gemtuzumab ozogamicin within 6 months (3)Pregnant or during breast feeding (4)Patients with other malignant comorbidity (5)Uncontrolled psychiatric disease (6)Uncontrolled active infection (7)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen. (8)Impaired organ function (a)left ventricular ejection fraction smaller than 40% (b)FEV1.0 and TLC less than 30% (c)AST or ALT over 5xULN(NCI-CTCAE Grade 3) (d)serum creatinine over 3xULN(NCI-CTCAE Grade 3) (9)Re-transplant within 1 year from the previous transplantation (10)Cases that physicians judged as inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of survival with engraftment at 60 days post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events related to intra-bone-marrow injection, term to hematopoietic recovery, treatment-associated toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, transplant-related mortality, relapse rate, disease-free survival, overall survival, causes of death | — |
Countries
Japan
Contacts
Public ContactMakoto Murata
Nagoya University Graduate School of Medicine Department of Hematology and Oncology
Outcome results
None listed