Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Mesenchymal Stem Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by Universitair Ziekenhuis Brussel
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01092026
First received: March 23, 2010
Last updated: November 9, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Allogeneic Stem Cell Transplantation
Other: cord blood transplantation
Phase 1
Phase 2

Study Type: Interventional
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

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • treatment-related mortality [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hematopoietic recovery [ Time Frame: One year after transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
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)
Intervention Details:
    Other: cord blood transplantation
    One or two cord blood transplants with co-infusion of third-party mesenchymal stem cells after pre-transplant preparative regimen
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Sensitive relapse after autologous HSCTx
  • T-prolymphocytic leukemia
  • Chronic lymphocytic leukemia
  • Refractory to fludarabine
  • Adverse karyotypes (del p17)
  • Chronic myeloid leukemia
  • Refractory or intolerant to second-line tyrosine kinase inhibitors
  • Multiple myeloma
  • Advanced disease (selected cases)
  • Informed consent given

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092026

Contacts
Contact: Rik Schots, MD, PhD +3224763105 Rik.Schots@uzbrussel.be
Contact: An Blank +3224763373 ann.blank@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Rik Schots, MD, PhD    +3224763105    Rik.Schots@uzbrussel.be   
Contact: An Blank    +3224763373    ann.blank@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Rik Schots, MD, PhD UZ Brussel
  More Information

No publications provided

Responsible Party: Schots MD PhD, UZ Brussel
ClinicalTrials.gov Identifier: NCT01092026     History of Changes
Other Study ID Numbers: BHS-UCB2009
Study First Received: March 23, 2010
Last Updated: November 9, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on October 23, 2014