ClinicalTrials.gov
ClinicalTrials.gov Menu

Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Mesenchymal Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01092026
Recruitment Status : Unknown
Verified May 2016 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : March 24, 2010
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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 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 or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Other: cord blood transplantation Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: cord blood transplant
Eiligible patients receive cord blood transplantation with coinfusion of mesenchymal stem cells
Other: cord blood transplantation
One or two cord blood transplants with co-infusion of third-party mesenchymal stem cells after pre-transplant preparative regimen




Primary Outcome Measures :
  1. treatment-related mortality [ Time Frame: day 100 after transplant ]

Secondary Outcome Measures :
  1. Hematopoietic recovery [ Time Frame: One year after transplant ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092026


Contacts
Contact: Rik Schots, MD, PhD +3224763105 Rik.Schots@uzbrussel.be
Contact: Dorien Deneve +3224776040 Dorien.Deneve@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Rik Schots, MD, PhD    +3224776211    Rik.Schots@uzbrussel.be   
Contact: Dorien Deneve    +3224776040    Dorien.Deneve@uzbrussel.be.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Rik Schots, MD, PhD Universitair Ziekenhuis Brussel

Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01092026     History of Changes
Other Study ID Numbers: BHS-UCB2009
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: May 2016