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

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ClinicalTrials.gov Identifier: NCT00945126
Recruitment Status : Terminated
First Posted : July 23, 2009
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Bader, Johann Wolfgang Goethe University Hospital

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2006
Primary Completion Date : August 2017
Study Completion Date : August 2017

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.


Primary Outcome Measures :
  1. To evaluate engraftment after CD3/CD19 depletion of the graft [ Time Frame: within 1 year ]

Secondary Outcome Measures :
  1. To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets [ Time Frame: within 1 year ]


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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT00945126


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

Responsible Party: Peter Bader, Prof. Dr. med. Peter Bader, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT00945126     History of Changes
Other Study ID Numbers: ZKI-SCT-HAPLO-0106
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

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