Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Mesenchymal Stem Cells

NCT01092026 | Completed

• 1 other identifier: BHS-UCB2009
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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 Umbilical Cord Blood (UCB) Hematopoietic Stem Cell Transplantation (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 Belgian Hematology Society (BHS) transplant committee will establish a protocol review committee which will organize a central monitoring of the study. Within the context of allogeneic Hematopoietic Stem Cell Transplantation (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.

Conditions

Allogeneic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• treatment-related mortality

  death related to treatment procedures

  day 100 after transplant

Secondary Outcomes (1)

• Hematopoietic recovery

  One year after transplant

Study Arms (1)

cord blood transplant

EXPERIMENTAL

Eligible patients receive cord blood transplantation with coinfusion of mesenchymal stem cells

Other: cord blood transplantation

Interventions

cord blood transplantation OTHER

One or two cord blood transplants with co-infusion of third-party mesenchymal stem cells after pre-transplant preparative regimen

cord blood transplant

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Allogeneic stem cell transplantation is the preferred treatment option:
• High risk acute myeloid leukemia (AML) in first complete remission (CR)
• Preceding myelodysplastic syndrome
• High risk karyotypes (e.g. monosomy 5 or 7, complex)
• FLT3 alteration
• \> 2 cycles to obtain CR
• Erythroblastic or megakaryocytic leukemia
• High risk acute lymphoblastic leukemia (ALL) in first CR
• High risk karyotypes (e.g. t\[9;22\], t\[4;11\], t\[1;19\], complex)
• MLL rearrangements
• Acute leukemia in second or third remission
• High risk myelodysplastic syndrome: IPSS Intermediate-2 or high risk
• Advanced lymphoproliferative disorders
• Diffuse large B-cel non-Hodgkin lymphoma (NHL) or mantle cell NHL or
• B-prolymphocytic leukemia

You may not qualify if:

• Previous allogeneic transplant
• Progressive malignant disease
• Significant organ damage as a contraindication to allotransplantation
• Creatinine clearance \< 60 ml/min
• AST/ALT \> 3x normal value and/or serum bilirubin \> 3 mg/dL
• Cardiac failure (LVEF \< 50%)
• Clinical relevant pulmonary disease: DLCO \< 50% normal
• Significant psychiatric or neurological disorder
• Uncontrolled viral, fungal or bacterial infection
• Pregnancy
• HIV positive

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Interventions

Cord Blood Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Rik Schots, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 24, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 6, 2023

Record last verified: 2018-05

Locations

BE (1)