Hematologic NeoplasmsPhase 2NCT01332006
Intra-bone Cord Blood Transplantation
A Phase 2 study testing Intrabone injection and Intra-bone cord blood hematopoietic stem cell transplantation in people with Hematologic Neoplasms, run by Università degli Studi di Brescia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Intrabone injection and Intra-bone cord blood hematopoietic stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor.
- Informed consent.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
USD TMO Adulti, Piazzale Spedali Civili
Brescia, 25100
Michele Malagola, Medical Doctor, +39/030/3996811, malagola@med.unibs.it
About this study
Official title: 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.
Read more
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.
- Conditions
- Hematologic Neoplasms
- Being tested
- Intrabone injection, Intra-bone cord blood hematopoietic stem cell transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrabone injectionProcedure or surgery
Also called Intrabone Transplant
All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.
Intra-bone cord blood hematopoietic stem cell transplantationBiological
Intra-bone cord blood hematopoietic stem cell transplantationBiological
Also called No other name
Intra-bone injection of CB hematopoietic SCs after conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| Intra-bone injection | Experimental | Intra-bone transplantation of hematopoietic stem cells from cord blood Receives: Procedure: Intrabone injection; Biological: Intra-bone cord blood hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of transplanted patients with successful engraftment at day +30
Engraftment
Measured: 30 days post transplantation
Secondary outcomes (5)
Clinical response with the analysis of global survival, survival without relapse, relapse incidence
Measured: 3 years from transplantation
Infections' Incidence
Measured: One year after transplantation
Chimerism monitoring on selected cell populations
Measured: Every three months and until one year after transplantation
Immunological reconstitution
Measured: One year after transplantation
Acute an Chronic GVHD
Measured: One year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domenico Russo, Università degli Studi di Brescia
- Investigators
- Domenico Russo, Full Professor, Principal investigator, USD TMO Adulti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332006
- Sponsor's protocol ID
- IBMCB - BS study
- Status last verified
- Nov 2018
- First submitted
- 6 Apr 2011
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor
- ClinicalTrials.gov ID
- NCT01332006
- Acronym / sponsor ID
- IBMCB - BS study
- Conditions
- Hematologic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-bone injection | Experimental | Procedure: Intrabone injection, Biological: Intra-bone cord blood hematopoietic stem cell transplantationIntra-bone transplantation of hematopoietic stem cells from cord blood |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years.
- Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor.
- Informed consent.
Key exclusion criteria (11 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrabone injectionAlso: Intrabone TransplantAll adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB. | Procedure or surgery | Intra-bone injection |
| Intra-bone cord blood hematopoietic stem cell transplantation | Biological | Intra-bone injection |
| Intra-bone cord blood hematopoietic stem cell transplantationAlso: No other nameIntra-bone injection of CB hematopoietic SCs after conditioning regimen | Biological | Intra-bone injection |
Primary outcome
Proportion of transplanted patients with successful engraftment at day +30
Time frame: 30 days post transplantation
Engraftment
5 secondary outcomes
Clinical response with the analysis of global survival, survival without relapse, relapse incidence
Time frame: 3 years from transplantation
Infections' Incidence
Time frame: One year after transplantation
Chimerism monitoring on selected cell populations
Time frame: Every three months and until one year after transplantation
Immunological reconstitution
Time frame: One year after transplantation
Acute an Chronic GVHD
Time frame: One year after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Russo, Full Professor principal investigator
USD TMO Adulti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrabone injection and Intra-bone cord blood hematopoietic stem cell transplantation in people with Hematologic Neoplasms, run by Università degli Studi di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof Domenico Russo, Full Professor (+39/030/3996812, russo@med.unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of transplanted patients with successful engraftment at day +30 (time frame: 30 days post transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.