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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.


- candidate number4661
- NTR NumberNTR1573
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-dec-2008
- Secondary IDsCCMO NL 18416.000.08 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMEngraftment after double cord blood transplantation.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia , Non Hodkin's lymfoma (NHL), Chronic Myeloid Leukemia (CML), Myelodysplastic syndrome (MDS), Chronic Lymfocytic Leukemia (CLL), Hematological malignancy, Allogeneic stem cell transplantation, Donor , Aplastic anemia
- Inclusion criteria1. Age 18-65 years inclusive.
2. Meeting the criteria for a MUD allo SCT and high risk disease.
3. Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of =< 2 months in case of urgently needed allo SCT.
4. Availability of 2 sufficiently matched UCB grafts with a total nucleated cell count of at least 4x10.7/kg.
5. WHO performance status =< 2.
6. Written informed consent.
- Exclusion criteria1. Relapse APL.
2. Primary myelofibrosis.
3. Bilirubin and/or transaminases > 2.5 x normal value.
4. Creatinine clearance < 40 ml/min.
5. Cardiac dysfunction as defined by:
- reduced left ventricular function with an ejection fraction < 45% as measured by MUGA scan or echocardiogram
- unstable angina or unstable cardiac arrhythmias.
6. Pulmonary function test with VC, FEV1 and/ or DCO < 50%.
7. Active, uncontrolled infection.
8. History of high dose total body irradiation.
9. HIV positivity.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 26-nov-2008
- planned closingdate31-dec-2010
- Target number of participants40
- InterventionsPatients 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, consisting of cyclophosphamide 60 mg/kg, fludarabine 4x40 mg/kg and TBI 2x2 Gy. Prophylaxis for graft-versus-host disease consists of cyclosporine-A and mycophenolate mofetil.
After transplantation blood and bone marrow samples will be drawn to study the mechanism of engraftment.
- Primary outcomeThe cumulative incidence of graft failure.
- Secondary outcome1. Time to engraftment of different cell subset';
2. time to platelet transfusion independence;
3. time to red blood cell transfusion independence;
4. incidence and grade of acute GVHD;
5. incidence of chronic GVHD;
6. incidence of infections;
7. transplant related mortality (TRM);
8. progression free survival and overall survival.
- TimepointsEvaluation of engraftment will take place at 1, 2, 3, 6, 12, and 24 months after transplantation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. J.A.E. Somers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J. Cornelissen
- Sponsor/Initiator Erasmus Medical Center, Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sanquin Blood Supply
- PublicationsN/A
- Brief summaryBackground:
Many adult patients with a high risk hematological disease can not proceed to allogeneic stem cell transplantation because they lack a matched unrelated stem cell donor. Cord blood is an important alternative stem cell source in children. In adult patients single cord blood transplantation is associated with a high rate of graft failure and a delayed hematopoietic recovery due to the small number of hematopoietic stem cells in a single cord blood unit. It has been shown that double cord blood transplantation is a safe and promising approach 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.

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.

Study population:
Patients with high risk haematological disease qualifiying for allogeneic stem cell transplantation but lacking a matched unrelated donor.

End points:
The primary endpoint is the cumulative incidence of graft failure.
The secundary end points are: time to engraftment of different cell lines, incidence of graft vs host disease, incidence of infection, TRM, disease-free survival and overall survival.
- Main changes (audit trail)
- RECORD3-dec-2008 - 7-jan-2009


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