Patients with high-risk hematological diseases, who need a allogeneic stem cell transplantation but who lack a matched unrelated donor
Conditions
Interventions
Product Name: Cord blood unit
Pharmaceutical Form:
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 65 years old or younger. High risk disease as specified in protocol. Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required timeperiod of no more than 2 months in case of urgently needed alloSCT. Availability of 2 sufficiently matched UCB grafts with a total nulear cell count > 4 x 10 7/kg. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Bilirubin and/of transaminases > 2.5 x normal value. Creatinine clearance < 40 ml/min. Active, uncontrolled infection. Cardiac dysfunction. Pulmonary dysfunction test with VC, FEV1 and/of DCO < 50%. History of high/dose total body irradiation. HIV positivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of engraftment and disease-free survival following double cord blood transplantation after a reduced intensity conditioning regimen in adult patients. In addition to description of clinical parameters biological studies will be performed in order to evaluate whether parameters can be identified that predict which graft ultimately prevails.;Secondary Objective: Evaluation of time to engraftment of different cell lines, incidence of graft versus host disease, transplant related mortality, disease-free survival and overall survival.;Primary end point(s): Cumulative incidence of graft failure | — |
Countries
Netherlands
Outcome results
None listed