- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01332006
Intra-bone Cord Blood Transplantation
Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor
For the great majority of hematological malignancies, hemopoietic stem cell (HSC) transplant is the only possible cure. The source of HSC is usually bone marrow (BM) or peripheral blood cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible donor weather related or unrelated. A suitable compatible donor can be found in at least 70% of the patients. Thus, at least 30% of patients with indication for allogeneic HSC transplant are not able to undergo the procedure because of the lack of a HLA compatible donor. Cord blood (CB) cells represent another possible source, that needs a lower degree of HLA compatibility. CB transplant, however, offers a lower number of HSC. Thus, adult patient rarely may benefit from this source of stem cells, mainly beacuse thie body weight is too high to have ad adequate number of cell per kg. Recently, experimental animal models confirmed that an adequate recovery of allogeneic hemopoiesis can be achieved via intrabone injection, using a 1Log lower number of cells compared to the intravenous way (Yahata 2003, Castello 2004). Safety and feasibility of intrabone infusion was verified by two clinical studies on humans: the first was conducted by Ringden O. et al. in 18 patients using BM as a source of SC. No side effects and complete engraftment of donor hemopoiesis was observed; the second one was conducted by Frassoni et al. (Frassoni 2008) with CB as the source of HSC.
The aim of this study is to evaluate the intrabone infusion of compatible CB in patients with haematological malignancies lacking a HLA matched donor.
We will perform:
evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100 days, 6 months and 1 year after transplant; studies on immunological reconstitution and the role of the NK compartment.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Prof Domenico Russo, Full Professor
- Phone Number: +39/030/3996812
- Email: russo@med.unibs.it
Study Locations
-
-
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Brescia, Italy, 25100
- Recruiting
- USD TMO Adulti, Piazzale Spedali Civili
-
Contact:
- Michele Malagola, Medical Doctor
- Phone Number: +39/030/3996811
- Email: malagola@med.unibs.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intra-bone injection
Intra-bone transplantation of hematopoietic stem cells from cord blood
|
All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.
Other Names:
Intra-bone injection of CB hematopoietic SCs after conditioning regimen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of transplanted patients with successful engraftment at day +30
Time Frame: 30 days post transplantation
|
Engraftment
|
30 days post transplantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical response with the analysis of global survival, survival without relapse, relapse incidence
Time Frame: 3 years from transplantation
|
3 years from transplantation
|
Infections' Incidence
Time Frame: One year after transplantation
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One year after transplantation
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Chimerism monitoring on selected cell populations
Time Frame: Every three months and until one year after transplantation
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Every three months and until one year after transplantation
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Immunological reconstitution
Time Frame: One year after transplantation
|
One year after transplantation
|
Acute an Chronic GVHD
Time Frame: One year after transplantation
|
One year after transplantation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Domenico Russo, Full Professor, USD TMO Adulti
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBMCB - BS study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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