Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells

Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01919866

Enrollment

120

Registered

2013-08-09

Start date

2004-03-31

Completion date

2015-12-31

Last updated

2014-10-08

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

Conditions

Acute Leukemias, Aplastic Anemia, Childhood Solid Tumor

Brief summary

Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.

Interventions

OTHERTransplantation of CD3/CD19 depleted stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 25 Years

Healthy volunteers

Inclusion criteria

* patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease) * AML in complete remission of refractory * MDS RAEB-t/secondary AML * ALL * CML * Non-Hodgkin Lymphoma / Hodgkin Lymphoma * non malignant diseases (aplastic anemia, thalassemia, SCID) * relapsed Neuroblastoma * relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET * soft tissue sarcoma with primary bone metastases or bone marrow * in whom no matched donor was available,

Exclusion criteria

* \< 6 months after previous HSCT * active cerebral seizure conditions * massive progression of leukemias or solid tumours before planned trp. * left ventricular ejection fraction \<25% * creatinine clearance \<40ml/min before conditioning * respiratory insufficiency with oxygen demand or DLCO \<30% * Bilirubin \>4mg/dl, GOT/GPT \>400 * severe infection (HIV, Aspergillosis) * pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Engraftment rate and transplant related mortality	365 days	engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: \>500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant

Secondary

Measure	Time frame	Description
Graft versus Host disease and speed of immune reconstitution	365 days	Incidence of acute and chronic GvHD will be evaluated according to Glucksberg criteria. Immune recovery will be evaluated by flow cytometry. Percentages and numbers of T, B and NK cells will be measured weekly until day 100, afterwards on day 180 and 365.

Countries

Austria, Germany

Contacts

Primary ContactPeter Lang, MD

peter.lang@med.uni-tuebingen.de+4970712981386

Backup ContactRupert Handgretinger, MD

rupert.handgretinger@med.uni-tuebingen.de+4970712984744

Outcome results

None listed

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