Refractory hematological malignancies
Conditions
Interventions
The purpose of this study is to investigate the efficacy of a combination of fludarabine, cyclophosphamide and total body irradiation as a conditioning regimen of reduced-intensity cord blood transpla
Sponsors
Nagoya Blood and Marrow Transplantation Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)not Available of appropriate sibling donor (2)likely to fail the coordination or not get time to coordinate judged by the attending physician (3) hematological malignancies who have an indication for allogeneic stem cell transplantation Either patients with AML or CML or MDS or CMMOL, (a) Age between 15 and 65 years and, 1)KS is 70 or less, or 2)a) Age between 40 and 54 years ,Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) is over 2 point at one month before the transplantation, b) Age under 40 years ,. Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) is over 3 point at one month before the transplantation. (b) (b) First allogenic stem cell transplantation (c) Written informed consent to participate the trial (d) FEV1%/ predicted vital capacity is 30% or more of predictive value (e) AST/ALT is under 5xULN (f) serum creatinin is under 3xULN (g) left ventricular ejection fraction is over 40%
Exclusion criteria
Exclusion criteria: (1)Positive for HIV antibody and/or HBs antigen and/or HCV antibody.(2)Graft manipulation such as T-cell depletion .(3)History of administration of gemtuzumab ozogamicin within 6 month before transplantation.(4)Pregnant or during breast feeding. (5)Uncontrolled active psychiatric disease. (6)Uncontrolled active infection. (7)Allergic history to drugs used in the conditioning regimen or GVHD prophylaxis regimen. (8)Patients with severe organ dysfunction. (9)Patients suggested as ineligible by their attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate of patients with successful engraftment at 60 days post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Time to hematopoietic recovery, (2)grade of treatment-associated toxicity by day28, (3)incidence and severity of acute GVHD, (4)incidence and severity of pre-engraftment syndrome , (5)incidence of engraftment syndrome, (6)incidence and severity of chronic GVHD, (7)treatment-related mortality rate at day100, (8)relapse rate at day100, (9)disease-free survival 1years after transplantation, (10)overall survival 1years after transplantation, (11)cause of death, (12)achievement of complete chimera at day 60 | — |
Countries
Japan
Contacts
Public ContactMasashi Sawa
Anjo Kosei Hospital Department of Hematology and Oncology
Outcome results
None listed