A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.
Phase 2
Completed
- Conditions
- Acute LeukemiaCancer of bone marrow10024324
- Registration Number
- NL-OMON35273
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
Exclusion Criteria
Bilirubin and/of transaminases > 2.5 x normal value. Creatininge clearance < 40 ml/min. Active, uncontrolled infection. Cardia dysfunction. Pulmonary dysfunction test with VC, FEV1 and/of DCO < 50%. History of high/dose total body irradiation. HIV positivity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the cumulative incidence of graft failure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary end points: time to engraftment of different cell lines, incidence of<br /><br>graft vs host disease, incidence of infection, TRM, disease-free survival and<br /><br>overall survival.</p><br>