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Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases

This study has suspended participant recruitment.
(Possible changes of trial subjects)
Sponsor:
Information provided by (Responsible Party):
Peter Bader, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00945126
First received: July 21, 2009
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.


Condition Intervention Phase
Malignant and Non-malignant High Risk Diseases
 Other: Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells of Related or Unrelated Haploidentical Donors in Pediatric Patients With Malignant and Non-malignant Diseases

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • To evaluate engraftment after CD3/CD19 depletion of the graft [ Time Frame: within 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets [ Time Frame: within 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: December 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS
    The aim is to transplant 7x106 CD34+/kg of recipient body weight.
  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 0 to 30 years
  • Written informed consent from patient and/or parents or guardian
  • Patients with Karnofsky Index > 60%

  • Malignant disease:

    • acute lymphoblastic leukemia
    • acute myeloid leukemia
    • myelodysplastic syndrome
    • chronic myeloid leukemia according to the standard indications

    • solid tumors (e.g. neuroblastoma recurrence, soft-tissue sarcoma, Ewing's sarcoma, osteosarcoma, hepatoblastoma)

      . Non malignant disease:

    • acquired anemias (e.g. severe aplastic anemia, particularly severe Evans syndrome)
    • congenital anemias (e.g. thalassemia and sickle cell anemia)
  • Women reliable contraception method when appropriate

Exclusion Criteria:

  • Participation in other clinical trials
  • Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
  • Pregnant or nursing women
  • Patients who underwent a stem cell transplantation in the last 250 days
  • Patients with kidney, heart or liver insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945126

Locations
Germany
Hospital for Children and Adolescents III, Division for Stem Cell Transplantation, Goethe University Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Peter Bader, Professor Hospital for Children and Adolescents III, Division for Stem Cell Transplantation, Goethe University Frankfurt/M.
  More Information

No publications provided

Responsible Party: Peter Bader, Prof. Dr. med. Peter Bader, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00945126     History of Changes
Other Study ID Numbers: ZKI-SCT-HAPLO-0106
Study First Received: July 21, 2009
Last Updated: May 15, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Allogeneic stem cell transplantation in pediatric patients
CD3/CD19 depleted stem cells
malignant and non-malignant diseases
malignant and non-malignant high risk diseases in pediatric patients

ClinicalTrials.gov processed this record on May 21, 2013