Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells

October 7, 2014 updated by: Peter Lang, University Children's Hospital Tuebingen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engraftment rate and transplant related mortality
Time Frame: 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
365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft versus Host disease and speed of immune reconstitution
Time Frame: 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.
365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital Tuebingen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1075/01 PEI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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