Status:
COMPLETED
Intrabone Infusion of Cord Blood in Adults With Hematological Malignancies
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the engraftment of donor hemopoiesis (proportion of transplanted patients with successful engraftment at day +42) in adult patients affected by high risk hemat...
Detailed Description
For many hematological malignancies, hemopoietic stem cell (HSC) transplant is the only possible treatment. The source of HSC is often bone marrow (BM) or, in the past 10 years, peripheral blood cell ...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years.
- Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor.
- Informed consent.
Exclusion
- Patients with ECOG \< 2.
- Patients with blood creatine \> 2 mg/dl or with transaminase or cholestase index \> 5 times compared to normality upper limits.
- Patients with Cardiac Fraction Ejection \< 40%.
- Patients with DLCO \< 60% or Diffusing Lung Capacity of carbon monoxide attesting a severe pulmonary insufficiency.
- Patients with peripheral blast cell count over 10%.
- Second neoplasia diagnosed no more than 2 years before.
- Patients with active or suspected infection by fungi for which a therapeutic treatment is ongoing.
- HIV positive patients.
- HCV-RNA and HBV-RNA positive patients (it is possible to enrol them after discussion with the Principal Investigator).
- Pregnant or lactating women.
- Severe mental diseases.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00886522
Start Date
April 1 2009
End Date
May 1 2013
Last Update
March 19 2021
Active Locations (1)
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1
Hematology Institute "L. and A. Seràgnoli", S. Orsola-Malpighi University Hospital
Bologna, Italy, 40138