Trial Information
Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
Inclusion Criteria:
- Advanced or High Risk Haematological Malignancies
- Age 18-65 years
- no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
- Informed consent
Exclusion Criteria:
- Active infectious disease at inclusion
- HIV- positivity or active hepatitis infection
- Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper
normal limit) at inclusion
- Impaired renal function (Creatinine-clearance <60 ml/min; Serum Creatinine >1.5 x
upper normal limit) at inclusion
- Psychiatric diseases or conditions that might impair the ability to give informed
consent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to neutrophil recovery
Outcome Time Frame:
28 days after transplantation
Safety Issue:
No
Principal Investigator
Daniele Mattei, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
ASO S Croce e Carle
Authority:
Italy: Ethics Committee
Study ID:
Emato68
NCT ID:
NCT01613066
Start Date:
November 2008
Completion Date:
May 2013
Related Keywords:
- High Risk Haematological Malignancies
- Advanced Haematological Malignancies
- Haematological malignancies
- Allogeneic Cord Blood transplantation
- Intrabone
- Neoplasms
- Hematologic Neoplasms