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…
ID
Source
Brief title
Condition
- Leukaemias
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the cumulative incidence of graft failure.
Secondary outcome
Secundary end points: time to engraftment of different cell lines, incidence of
graft vs host disease, incidence of infection, TRM, disease-free survival and
overall survival.
Background summary
Many adults with high risk hematological disease can not proceed to allogeneic
stem cell transplantation because they lack a matched unrelated stem cell
donor. Cord blood transplantation has shown to be an important alternative stem
cell source in children. The major problem after a single cord blood
transplantation in adults appears to be primary graft failure and a delayed
hematopoietic recovery caused by the small number of hematopoietic stem cells
in cord blood grafts. Double cord blood transplantation has shown to be a safe
and promising approach in adult to overcome this problem. Sustained
hematopoiesis is usually derived from a single donor after double umbilical
cord blood transplantation.So far, the distinct contributing factors which lead
to the predominance of the prevailing cord blood graft are not known.
Study 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.
Study design
Prospective phase II study. Patients eligible for allogeneic stem cell
transplantation lacking a matched unrelated donor are transplanted with a
double cord blood graft. Transplantation will be preceded by a
reduced-intensity conditioning regimen. After transplantation blood samples and
bone marrow samples will be collected at certain time points.
Intervention
a
Study burden and risks
Nature and extend of the burden and risks associated with participation
Burden and risk are comparable to burden and risk of a standard cord blood
transplant procedure. Collection of blood samples may be a small extra burden
if extra venous puncture is necessary. Collection of bone marrow samples can
give a small inconvenience because a larger volume of bone marrow has to be
collected compared to standard bone marrow examination.
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000053-35-NL |
| CCMO | NL18416.000.08 |