Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells

Sponsor

University Children's Hospital Tuebingen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01919866

Collaborator

(none)

120

Enrollment

Locations

Arm

141

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemias Aplastic Anemia Childhood Solid Tumor	Other: Transplantation of CD3/CD19 depleted stem cells	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transplantation of CD3/CD19 depleted stem cells Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW	Other: Transplantation of CD3/CD19 depleted stem cells

Arm

Intervention/Treatment

Experimental: Transplantation of CD3/CD19 depleted stem cells

Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW

Other: Transplantation of CD3/CD19 depleted stem cells

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 25 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Children's Hospital	Graz	Austria	8036
2	University Children's Hospital	Halle	Germany	6120
3	Medizinische Hochschule Zentrum für Kinderheilkunde	Hannover	Germany	30625
4	University Children's Hospital	Jena	Germany	7745
5	University Children's Hospital	Tuebingen	Germany	72076

Sponsors and Collaborators

University Children's Hospital Tuebingen

Investigators

Principal Investigator: Peter Lang, MD, University Children's Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Lang, Prof. Dr. med., University Children's Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT01919866

Other Study ID Numbers:

1075/01 PEI

First Posted:

Aug 9, 2013

Last Update Posted:

Oct 8, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Anemia, Aplastic

Study Results

No Results Posted as of Oct 8, 2014