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

Tracking Information

First Received Date ^ICMJE

July 21, 2009

Last Updated Date

May 15, 2012

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00945126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Malignant and Non-malignant High Risk Diseases

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 30 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00945126

Other Study ID Numbers ^ICMJE

ZKI-SCT-HAPLO-0106

Has Data Monitoring Committee

Responsible Party

Peter Bader, Johann Wolfgang Goethe University Hospitals

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Bader, Professor

Hospital for Children and Adolescents III, Division for Stem Cell Transplantation, Goethe University Frankfurt/M.

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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