Hematological MalignanciesPhase 2IBCBNCT00886522
Intrabone Infusion of Cord Blood in Adults With Hematological Malignancies
A Phase 2 study testing Intrabone cord blood infusion in people with Hematological Malignancies, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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 hematological malignancies after intrabone infusion of cord blood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Intrabone cord blood infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to May 2013
- 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-RNA positive patients (it is possible to enrol them after discussion with the Principal Investigator).
- Pregnant or lactating women.
- Severe mental diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hematology Institute "L. and A. Seràgnoli", S. Orsola-Malpighi University Hospital
Bologna, 40138
About this study
Official title: Intrabone Infusion of Cord Blood Hemopoietic Stem Cells in Adult Patients With High Risk Haematological Malignancies.
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 hematological malignancies after intrabone infusion of cord blood.
Read the 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 (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible (related or unrelated) donor. Around 10-30% 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, which needs a lower degree of HLA compatibility, this type of transplant, however, offers a lower number of HSC. For this reason, adult patients, until now, could not use this source, because of the not suitable number of cell per kg, of recipient body weight. Recently, in experimental animal models it was observed that intrabone HSC transplant allows, in the recipient, engraftment of donor hemopoiesis by using a 1Log (10-1) 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 without any evidence of collateral effects and with complete engraftment of donor hemopoiesis with BM as a source of HSC (Hagglund 1998); 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 instead of the intravenous one, for the HSC transplant from CB in patients with haematological malignancies when it is not possible to find 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.
- Conditions
- Hematological Malignancies
- Being tested
- Intrabone cord blood infusion
- Keywords
- Anti-thymocyte globulin Fresenius, Busulfan, Cord blood, Cyclophosphamide, Fludarabine, Human Leucocyte Antigen, Hematopoietic Stem Cell, Hematopoietic Stem Cell Transplant, Graft-versus-Host-Disease, Graft-versus-Host-Disease prophylaxis, Intrabone infusion, Thiotepa
- Medical subject headings
- Hematologic Neoplasms, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrabone cord blood infusionProcedure or surgery
Myeloablative conditioning regimen (MAC):
i.v. Busulfan 12.8 mg/kg, Cyclophosphamide 120 mg/kg, ATG-Fresenius 30 mg/kg
Reduced intensity conditioning regimen (RIC):
Tiothepa 10 mg/kg, Fludarabine 100 mg/kg, Cyclophosphamide 100 mg/kg, ATG-Fresenius 30 mg/kg
GVHD prophylaxis:
Cyclosporine 1 mg/kg since day -7 to +120, Mycophenolate 15 mg kg x 2 since day +1 to +27
| Study group | Role | What they receive |
|---|---|---|
| Intrabone cord blood infusion | Experimental | All adults patients with hematological malignancies, lacking a HLA matched donor but with a HLA compatible CB unit, fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB. Receives: Procedure: Intrabone cord blood infusion |
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 +42
Measured: Within the first 42 days
Secondary outcomes (5)
Clinical response with the analysis of global survival, survival without relapse, relapse incidence
Measured: 1 year
Acute and chronic GVHD incidence
Measured: For acute GVHD 100 days; for chronic GVHD 1 year
Infection incidence
Measured: 1 year
Chimerism study on selected populations (myeloid, lymphoid, NK)
Measured: 30, 60, 100 days, 6 months and 1 year
Studies on immunological reconstitution
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Bonifazi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Francesca Bonifazi, MD, Principal investigator, S. Orsola-Malpighi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886522
- Sponsor's protocol ID
- 152/2008/U/Sper
- Acronym
- IBCB
- Status last verified
- Mar 2021
- First submitted
- 22 Apr 2009
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ballen KK, Spitzer TR, Yeap BY, McAfee S, Dey BR, Attar E, Haspel R, Kao G, Liney D, Alyea E, Lee S, Cutler C, Ho V, Soiffer R, Antin JH. Double unrelated reduced-intensity umbilical cord blood transplantation in adults. Biol Blood Marrow Transplant. 2007 Jan;13(1):82-9. doi: 10.1016/j.bbmt.2006.08.041.
PubMed 17222756Barker JN, Davies SM, DeFor T, Ramsay NK, Weisdorf DJ, Wagner JE. Survival after transplantation of unrelated donor umbilical cord blood is comparable to that of human leukocyte antigen-matched unrelated donor bone marrow: results of a matched-pair analysis. Blood. 2001 May 15;97(10):2957-61. doi: 10.1182/blood.v97.10.2957.
PubMed 11342417Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003 Sep 1;102(5):1915-9. doi: 10.1182/blood-2002-11-3337. Epub 2003 May 8.
PubMed 12738676Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. doi: 10.1182/blood-2004-07-2717. Epub 2004 Oct 5.
PubMed 15466923Bradley MB, Satwani P, Baldinger L, Morris E, van de Ven C, Del Toro G, Garvin J, George D, Bhatia M, Roman E, Baxter-Lowe LA, Schwartz J, Qualter E, Hawks R, Wolownik K, Foley S, Militano O, Leclere J, Cheung YK, Cairo MS. Reduced intensity allogeneic umbilical cord blood transplantation in children and adolescent recipients with malignant and non-malignant diseases. Bone Marrow Transplant. 2007 Oct;40(7):621-31. doi: 10.1038/sj.bmt.1705785. Epub 2007 Jul 30.
PubMed 17660841Brunstein CG, Barker JN, Weisdorf DJ, DeFor TE, Miller JS, Blazar BR, McGlave PB, Wagner JE. Umbilical cord blood transplantation after nonmyeloablative conditioning: impact on transplantation outcomes in 110 adults with hematologic disease. Blood. 2007 Oct 15;110(8):3064-70. doi: 10.1182/blood-2007-04-067215. Epub 2007 Jun 14.
PubMed 17569820Cornetta K, Laughlin M, Carter S, Wall D, Weinthal J, Delaney C, Wagner J, Sweetman R, McCarthy P, Chao N. Umbilical cord blood transplantation in adults: results of the prospective Cord Blood Transplantation (COBLT). Biol Blood Marrow Transplant. 2005 Feb;11(2):149-60. doi: 10.1016/j.bbmt.2004.11.020.
PubMed 15682076Cohen Y, Nagler A. Umbilical cord blood transplantation--how, when and for whom? Blood Rev. 2004 Sep;18(3):167-79. doi: 10.1016/S0268-960X(03)00064-X.
PubMed 15183901De Witte T, Van Biezen A, Hermans J, Labopin M, Runde V, Or R, Meloni G, Mauri SB, Carella A, Apperley J, Gratwohl A, Laporte JP. Autologous bone marrow transplantation for patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia following MDS. Chronic and Acute Leukemia Working Parties of the European Group for Blood and Marrow Transplantation. Blood. 1997 Nov 15;90(10):3853-7.
PubMed 9354651Dick JE and Lapidot T. Stem cells take a shortcut to the bone marrow. Blood 2003(101):2901-2902.
Eapen M, Rubinstein P, Zhang MJ, Stevens C, Kurtzberg J, Scaradavou A, Loberiza FR, Champlin RE, Klein JP, Horowitz MM, Wagner JE. Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: a comparison study. Lancet. 2007 Jun 9;369(9577):1947-54. doi: 10.1016/S0140-6736(07)60915-5.
PubMed 17560447Fanning LR, Hegerfeldt Y, Tary-Lehmann M, Lesniewski M, Maciejewski J, Weitzel RP, Kozik M, Finney M, Lazarus HM, Paul P, Ratajczak MZ, Meyerson HJ, Laughlin MJ. Allogeneic transplantation of multiple umbilical cord blood units in adults: role of pretransplant-mixed lymphocyte reaction to predict host-vs-graft rejection. Leukemia. 2008 Sep;22(9):1786-90. doi: 10.1038/leu.2008.55. Epub 2008 Mar 20. No abstract available.
PubMed 18354493Frassoni F, Gualandi F, Podestà M et al. Direct intra-bone injection of unrelated cord blood cells overcomes the problem of delayed/failure to engraft and improves the feasibility of haematopoietic transplant in adult patients. Bone Marrow Transp 41(81):21, 2008.
Gluckman E, Broxmeyer HA, Auerbach AD, Friedman HS, Douglas GW, Devergie A, Esperou H, Thierry D, Socie G, Lehn P, et al. Hematopoietic reconstitution in a patient with Fanconi's anemia by means of umbilical-cord blood from an HLA-identical sibling. N Engl J Med. 1989 Oct 26;321(17):1174-8. doi: 10.1056/NEJM198910263211707. No abstract available.
PubMed 2571931Gluckman E, Rocha V, Arcese W, Michel G, Sanz G, Chan KW, Takahashi TA, Ortega J, Filipovich A, Locatelli F, Asano S, Fagioli F, Vowels M, Sirvent A, Laporte JP, Tiedemann K, Amadori S, Abecassis M, Bordigoni P, Diez B, Shaw PJ, Vora A, Caniglia M, Garnier F, Ionescu I, Garcia J, Koegler G, Rebulla P, Chevret S; Eurocord Group. Factors associated with outcomes of unrelated cord blood transplant: guidelines for donor choice. Exp Hematol. 2004 Apr;32(4):397-407. doi: 10.1016/j.exphem.2004.01.002.
PubMed 15050751
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrabone Infusion of Cord Blood Hemopoietic Stem Cells in Adult Patients With High Risk Haematological Malignancies.
- ClinicalTrials.gov ID
- NCT00886522
- Acronym / sponsor ID
- IBCB / 152/2008/U/Sper
- Conditions
- Hematological Malignancies
- Keywords
- Anti-thymocyte globulin Fresenius, Busulfan, Cord blood, Cyclophosphamide, Fludarabine, Human Leucocyte Antigen, Hematopoietic Stem Cell, Hematopoietic Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Apr 2009 (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.
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 hematological malignancies after intrabone infusion of cord blood.
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 (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible (related or unrelated) donor. Around 10-30% 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, which needs a lower degree of HLA compatibility, this type of transplant, however, offers a lower number of HSC. For this reason, adult patients, until now, could not use this source, because of the not suitable number of cell per kg, of recipient body weight. Recently, in experimental animal models it was observed that intrabone HSC transplant allows, in the recipient, engraftment of donor hemopoiesis by using a 1Log (10-1) 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 without any evidence of collateral effects and with complete engraftment of donor hemopoiesis with BM as a source of HSC (Hagglund 1998); 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 instead of the intravenous one, for the HSC transplant from CB in patients with haematological malignancies when it is not possible to find 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 |
|---|---|---|
| Intrabone cord blood infusion | Experimental | Procedure: Intrabone cord blood infusionAll adults patients with hematological malignancies, lacking a HLA matched donor but with a HLA compatible CB unit, fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB. |
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 cord blood infusionMyeloablative conditioning regimen (MAC): i.v. Busulfan 12.8 mg/kg, Cyclophosphamide 120 mg/kg, ATG-Fresenius 30 mg/kg Reduced intensity conditioning regimen (RIC): Tiothepa 10 mg/kg, Fludarabine 100 mg/kg, Cyclophosphamide 100 mg/kg, ATG-Fresenius 30 mg/kg GVHD prophylaxis: Cyclosporine 1 mg/kg since day -7 to +120, Mycophenolate 15 mg kg x 2 since day +1 to +27 | Procedure or surgery | Intrabone cord blood infusion |
Primary outcome
Proportion of transplanted patients with successful engraftment at day +42
Time frame: Within the first 42 days
5 secondary outcomes
Clinical response with the analysis of global survival, survival without relapse, relapse incidence
Time frame: 1 year
Acute and chronic GVHD incidence
Time frame: For acute GVHD 100 days; for chronic GVHD 1 year
Infection incidence
Time frame: 1 year
Chimerism study on selected populations (myeloid, lymphoid, NK)
Time frame: 30, 60, 100 days, 6 months and 1 year
Studies on immunological reconstitution
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 17222756Ballen KK, Spitzer TR, Yeap BY, McAfee S, Dey BR, Attar E, Haspel R, Kao G, Liney D, Alyea E, Lee S, Cutler C, Ho V, Soiffer R, Antin JH. Double unrelated reduced-intensity umbilical cord blood transplantation in adults. Biol Blood Marrow Transplant. 2007 Jan;13(1):82-9. doi: 10.1016/j.bbmt.2006.08.041.
- Background: PubMed 11342417Barker JN, Davies SM, DeFor T, Ramsay NK, Weisdorf DJ, Wagner JE. Survival after transplantation of unrelated donor umbilical cord blood is comparable to that of human leukocyte antigen-matched unrelated donor bone marrow: results of a matched-pair analysis. Blood. 2001 May 15;97(10):2957-61. doi: 10.1182/blood.v97.10.2957.
- Background: PubMed 12738676Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003 Sep 1;102(5):1915-9. doi: 10.1182/blood-2002-11-3337. Epub 2003 May 8.
- Background: PubMed 15466923Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. doi: 10.1182/blood-2004-07-2717. Epub 2004 Oct 5.
- Background: PubMed 17660841Bradley MB, Satwani P, Baldinger L, Morris E, van de Ven C, Del Toro G, Garvin J, George D, Bhatia M, Roman E, Baxter-Lowe LA, Schwartz J, Qualter E, Hawks R, Wolownik K, Foley S, Militano O, Leclere J, Cheung YK, Cairo MS. Reduced intensity allogeneic umbilical cord blood transplantation in children and adolescent recipients with malignant and non-malignant diseases. Bone Marrow Transplant. 2007 Oct;40(7):621-31. doi: 10.1038/sj.bmt.1705785. Epub 2007 Jul 30.
- Background: PubMed 17569820Brunstein CG, Barker JN, Weisdorf DJ, DeFor TE, Miller JS, Blazar BR, McGlave PB, Wagner JE. Umbilical cord blood transplantation after nonmyeloablative conditioning: impact on transplantation outcomes in 110 adults with hematologic disease. Blood. 2007 Oct 15;110(8):3064-70. doi: 10.1182/blood-2007-04-067215. Epub 2007 Jun 14.
- Background: PubMed 15682076Cornetta K, Laughlin M, Carter S, Wall D, Weinthal J, Delaney C, Wagner J, Sweetman R, McCarthy P, Chao N. Umbilical cord blood transplantation in adults: results of the prospective Cord Blood Transplantation (COBLT). Biol Blood Marrow Transplant. 2005 Feb;11(2):149-60. doi: 10.1016/j.bbmt.2004.11.020.
- Background: PubMed 15183901Cohen Y, Nagler A. Umbilical cord blood transplantation--how, when and for whom? Blood Rev. 2004 Sep;18(3):167-79. doi: 10.1016/S0268-960X(03)00064-X.
- Background: PubMed 9354651De Witte T, Van Biezen A, Hermans J, Labopin M, Runde V, Or R, Meloni G, Mauri SB, Carella A, Apperley J, Gratwohl A, Laporte JP. Autologous bone marrow transplantation for patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia following MDS. Chronic and Acute Leukemia Working Parties of the European Group for Blood and Marrow Transplantation. Blood. 1997 Nov 15;90(10):3853-7.
- BackgroundDick JE and Lapidot T. Stem cells take a shortcut to the bone marrow. Blood 2003(101):2901-2902.
- Background: PubMed 17560447Eapen M, Rubinstein P, Zhang MJ, Stevens C, Kurtzberg J, Scaradavou A, Loberiza FR, Champlin RE, Klein JP, Horowitz MM, Wagner JE. Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: a comparison study. Lancet. 2007 Jun 9;369(9577):1947-54. doi: 10.1016/S0140-6736(07)60915-5.
- Background: PubMed 18354493Fanning LR, Hegerfeldt Y, Tary-Lehmann M, Lesniewski M, Maciejewski J, Weitzel RP, Kozik M, Finney M, Lazarus HM, Paul P, Ratajczak MZ, Meyerson HJ, Laughlin MJ. Allogeneic transplantation of multiple umbilical cord blood units in adults: role of pretransplant-mixed lymphocyte reaction to predict host-vs-graft rejection. Leukemia. 2008 Sep;22(9):1786-90. doi: 10.1038/leu.2008.55. Epub 2008 Mar 20. No abstract available.
- The European Group for Blood and Marrow TransplantationLink provided by the sponsor.
- Italian Agency for Drugs (AIFA)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Francesca Bonifazi, MD principal investigator
S. Orsola-Malpighi University Hospital
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 cord blood infusion in people with Hematological Malignancies, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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: finished, as of the sponsor's last update on 19 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of transplanted patients with successful engraftment at day +42 (time frame: Within the first 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886522, which also lists 52 linked publications.
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 19 Mar 2021.