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

Malignant and Non-malignant High Risk Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00945126
• Other study ID #: ZKI-SCT-HAPLO-0106
• Status: Terminated
• Phase: Phase 2
• Start date: December 2006
• Est. completion date: August 2017

Study information

• Verified date: August 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant and Non-malignant High Risk Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate engraftment after CD3/CD19 depletion of the graft		within 1 year
Secondary	To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets		within 1 year