Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Mesenchymal Stem Cells
A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative conditioning in patients with hematological malignancies.
This is a multicenter single arm, phase I-II pilot study. The primary objective of this study is to determine the feasibility of UCB HSCT with co-infusion of third party mesenchymal stem cells as assessed by the treatment-related mortality at d100 after transplant.
Patient inclusion criteria:
Age 15-60 yrs Patients for whom allogeneic stem cell transplantation is the preferred treatment option, with the following hematological malignancies:acute myeloid leukemia, acute lymphoblastic leukemia, high risk myelodysplastic syndrome, advanced lymphoproliferative disorders, chronic myeloid leukemia (refractory or intolerant to second-line tyrosine kinase inhibitors), multiple myeloma Informed consent given Patient exclusion criteria Previous allogeneic transplant Progressive malignant disease Significant organ damage as a contraindication to allotransplantation Significant psychiatric or neurological disorder Uncontrolled viral, fungal or bacterial infection Pregnancy HIV positive Patients will receive either myeloablative or reduced intensity conditioning. One or 2 cord blood transplants will be transplanted, followed by infusion of a third-party mesenchymal stem cell transplant Adverse event reporting BHS transplant committee will establish a protocol review committee which will organize a central monitoring of the study. Within the context of allogeneic HSCTx many severe events are likely to occur.
Statistics and stopping rules The trial will be stopped at any time that there is reasonable evidence that the true rate of day +100 nonrelapse mortality exceeds 0.40. It is the intention to include an initial 20 patients.
Allogeneic Stem Cell Transplantation
Other: cord blood transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Assess the Feasibility of Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Third-party Mesenchymal Stem Cells After Myeloablative or Nonmyeloablative Conditioning in Patients With Hematological Malignancies|
- treatment-related mortality [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
- Hematopoietic recovery [ Time Frame: One year after transplant ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Other: cord blood transplantation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092026
|Contact: Rik Schots, MD, PhD||+3224763105||Rik.Schots@uzbrussel.be|
|Contact: An Blankfirstname.lastname@example.org|
|Brussel, Belgium, 1090|
|Contact: Rik Schots, MD, PhD +3224763105 Rik.Schots@uzbrussel.be|
|Contact: An Blank +3224763373 email@example.com|
|Principal Investigator:||Rik Schots, MD, PhD||UZ Brussel|