Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor
Phase 2
18 Years
65 Years
18 Years
65 Years
Open (Enrolling)
Both
Hematologic Neoplasms
Both
Hematologic Neoplasms
Trial Information
Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor
Inclusion Criteria:
- Age between 18 and 65 years.
- Patients affected by hematological malignancies without a HLA identical sibling donor
or unrelated donor.
- Informed consent.
Exclusion Criteria:
- 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-DNA positive patients
- Pregnant or lactating women.
- Severe mental diseases.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of transplanted patients with successful engraftment at day +30
Outcome Description:
Engraftment
Outcome Time Frame:
30 days post transplantation
Safety Issue:
Yes
Principal Investigator
Domenico Russo, Full Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
USD TMO Adulti
Authority:
Italy: Ethics Committee
Study ID:
IBMCB - BS study
NCT ID:
NCT01332006
Start Date:
November 2009
Completion Date:
June 2014
Related Keywords:
- Hematologic Neoplasms
- Neoplasms
- Hematologic Neoplasms
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