Clinical trial · Interventional
Intrabone Infusion of Cord Blood in Adults With Hematological Malignancies
Intrabone Infusion of Cord Blood Hemopoietic Stem Cells in Adult Patients With High Risk Haematological Malignancies.
NCT00886522CI-TRIAL-00050780IBCBcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrabone cord blood infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intrabone cord blood infusion
- description
- 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.
- interventionNames
- Procedure: Intrabone cord blood infusion
Primary outcomes (1)
- measure
- Proportion of transplanted patients with successful engraftment at day +42
- timeFrame
- Within the first 42 days
Secondary outcomes (5)
- measure
- Clinical response with the analysis of global survival, survival without relapse, relapse incidence
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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-RNA positive patients (it is possible to enrol them after discussion with the Principal Investigator). * Pregnant or lactating women. * Severe mental diseases.
References
Publications (52)
- BACKGROUNDBallen 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. PMID 17222756
- BACKGROUNDBarker 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. PMID 11342417
- BACKGROUNDBarker 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. PMID 12738676
- BACKGROUNDBarker 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. PMID 15466923
- BACKGROUNDBradley 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. PMID 17660841
- BACKGROUNDBrunstein 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.