Back to resultsSafety Study of CD3/CD19 Depleted Haploidentical Stem Cells
Primary Purpose
Acute Leukemias, Aplastic Anemia, Childhood Solid Tumor
Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Transplantation of CD3/CD19 depleted stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Leukemias
Eligibility Criteria
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
Sites / Locations
- University Children's HospitalRecruiting
- University Children's HospitalRecruiting
- Medizinische Hochschule Zentrum für KinderheilkundeRecruiting
- University Children's HospitalRecruiting
- University Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transplantation of CD3/CD19 depleted stem cells
Arm Description
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
Outcomes
Primary Outcome Measures
Engraftment rate and transplant related mortality
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
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.
Full Information
NCT ID
NCT01919866
First Posted
August 7, 2013
Last Updated
October 7, 2014
Sponsor
University Children's Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT01919866
Brief Title
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
Official Title
Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Children's Hospital Tuebingen
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemias, Aplastic Anemia, Childhood Solid Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transplantation of CD3/CD19 depleted stem cells
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Transplantation of CD3/CD19 depleted stem cells
Primary Outcome Measure Information:
Title
Engraftment rate and transplant related mortality
Description
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
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Graft versus Host disease and speed of immune reconstitution
Description
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.
Time Frame
365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Lang, MD
Phone
+4970712981386
Email
peter.lang@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rupert Handgretinger, MD
Phone
+4970712984744
Email
rupert.handgretinger@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lang, MD
Organizational Affiliation
University Children's Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Urban, MD
Email
christian.urban@medunigraz.at
Facility Name
University Children's Hospital
City
Halle
ZIP/Postal Code
6120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Mauz-Körholz, MD
Email
christine.mauz-koerholz@medizin.uni-halle
Facility Name
Medizinische Hochschule Zentrum für Kinderheilkunde
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Sauer, MD
Email
sauer.martin@mh-hannover.de
Facility Name
University Children's Hospital
City
Jena
ZIP/Postal Code
7745
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Gruhn, MD
Email
bernd.gruhn@med.uni-jena.de
Facility Name
University Children's Hospital
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Lang, MD
12. IPD Sharing Statement
Learn more about this trial
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
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