Intra-bone Cord Blood Transplantation

Hematologic Neoplasms Clinical Trial

Official title:

Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01332006
• Other study ID #: IBMCB - BS study
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2009
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Università degli Studi di Brescia
• Contact: Prof Domenico Russo, Full Professor
• Phone: +39/030/3996812
• Email: russo[@]med.unibs.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

Procedure:
• Intrabone injection
All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.

Biological:
• Intra-bone cord blood hematopoietic stem cell transplantation

• Intra-bone cord blood hematopoietic stem cell transplantation
Intra-bone injection of CB hematopoietic SCs after conditioning regimen

Locations

Country	Name	City	State
Italy	USD TMO Adulti, Piazzale Spedali Civili	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of transplanted patients with successful engraftment at day +30	Engraftment	30 days post transplantation
Secondary	Clinical response with the analysis of global survival, survival without relapse, relapse incidence		3 years from transplantation
Secondary	Infections' Incidence		One year after transplantation
Secondary	Chimerism monitoring on selected cell populations		Every three months and until one year after transplantation
Secondary	Immunological reconstitution		One year after transplantation
Secondary	Acute an Chronic GVHD		One year after transplantation