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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945126

Enrollment

Registered

2009-07-23

Start date

2006-12-31

Completion date

2017-08-31

Last updated

2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant and Non-malignant High Risk Diseases

Keywords

Allogeneic stem cell transplantation in pediatric patients, CD3/CD19 depleted stem cells, malignant and non-malignant high risk 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.

Interventions

OTHERHematopoietic 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 30 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate engraftment after CD3/CD19 depletion of the graft	within 1 year

Secondary

Measure	Time frame
To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets	within 1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026