Status:
UNKNOWN
T&B Depletion Non Malignant
Lead Sponsor:
Franco Locatelli
Collaborating Sponsors:
University of Milano Bicocca
medac GmbH
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
28-64 years
Phase:
PHASE2
Brief Summary
• The primary aim of the present trial is to assess in a randomized fashion the benefit on standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in transplants fro...
Detailed Description
For patients transplanted from a MRD The primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to: * primary and secondary graft failure, * aGV...
Eligibility Criteria
Inclusion
- non malignant haematological and inherited metabolic disorders benefiting from an allogeneic HSCT conditioned with a myeloablative regimen
- Availability of a matched related donor (MRD) or Matched Unrelated Donor (MUD)
- Lansky or Karnofsky Index ≥ 60
- Inherited metabolic disorders: DQ ≥ 70 (+ MRI Loes score ≤ 9 for adrenoleukodystrophy)
- Adequate cardiac, renal, hepatic and pulmonary functions as evidenced by:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
- Heart shortening fraction (left-ventricle) \> 28 % or LVEF \> 55%
- Serum bilirubin ≤ 1.5 × ULN (except for Wolman disease),
- AST and ALT ≤ 2.5 × ULN (except for thalassemic syndromes and Wolman disease)
- Pulmonary function: if cooperative: FEV1 and FVC on pulmonary function testing \> 60 %; if non cooperative: pulse oximetry \> 95 % in room air
- Availability of autologous back up marrow (\> 2 x 108 TNC+ cells/kg or \> 2 x 106 CD34+ cells/kg) for MUD
- Adequate contraception in female patients of child-bearing potential
- Signed informed consent
Exclusion
- Any malignancy
- Liver cirrhosis evidenced on liver histology (performed in suspicious cases or in case of Wolman disease)
- HIV- positivity
- Clinically significant pleural effusion or ascites
- Pregnancy or lactation
- Known hypersensitivity to trial drugs
- Participation in another experimental drug trial in the 2 months preceding enrollment
- Non-cooperative behaviour or non-compliance
- Previous HSCT
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01810926
Start Date
September 1 2011
End Date
October 1 2016
Last Update
March 14 2013
Active Locations (4)
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1
University of Cagliari
Cagliari, Italy, Italy, 09126
2
San Raffaele Scientific Institute
Milan, Italy, Italy, 20132
3
University of Milano-Bicocca San Gerardo Hospital
Monza, Italy, Italy, 20052
4
Bambino Gesù Hospital and Research Institute
Rome, Italy, Italy, 00165