Status:
COMPLETED
Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
Jazz Pharmaceuticals
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Hepatic Veno-Occlusive Disease
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are at high risk of de...
Detailed Description
Comparison/control intervention and duration of the intervention: Patients will be assigned randomly to either the Defibrotide (DF) prophylaxis arm or the control arm. Those allocated to the DF proph...
Eligibility Criteria
Inclusion
- Age \<18 years
- myeloablative conditioning and autologous or allogeneic stem cell transplantation with at least one of the following risk factors for VOD:
- Pre-existing liver disease
- Second myeloablative HSCT
- History of treatment with gemtuzumab ozogamicin (MYLOTARGÒ, GO, CMA-676, Wyeth)
- Allogeneic HSCT for leukemia beyond the second relapse
- Osteopetrosis (OP)
- Conditioning with busulfan and melphalan
- Macrophage activating syndromes (MAS, like hemophagocytic lymphohistiocytosis, Griscelli, Chediak-Higashi
- Adrenoleukodystrophy (ALD)
Exclusion
- Pregnant patients
- Patients who are transplanted but do not fulfill any of the above mentioned criteria
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00272948
Start Date
December 1 2005
End Date
July 1 2009
Last Update
June 9 2011
Active Locations (30)
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1
University Hospital
Graz, Austria
2
St Anna Kinderspital
Vienna, Austria
3
Inst. Gustave Roussy
Villejuif, France
4
University Hospital
Dresden, Germany