NCT01919866

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

10.8 years

First QC Date

August 7, 2013

Last Update Submit

October 7, 2014

Conditions

Acute LeukemiasAplastic AnemiaChildhood Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

    365 days

Secondary Outcomes (1)

  • Graft versus Host disease and speed of immune reconstitution

    365 days

Study Arms (1)

Transplantation of CD3/CD19 depleted stem cells

EXPERIMENTAL

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

Interventions

Transplantation of CD3/CD19 depleted stem cellsOTHER
Transplantation of CD3/CD19 depleted stem cells

Eligibility Criteria

Age1 Year - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Children's Hospital

Graz, 8036, Austria

RECRUITING

University Children's Hospital

Halle, 6120, Germany

RECRUITING

Medizinische Hochschule Zentrum für Kinderheilkunde

Hanover, 30625, Germany

RECRUITING

University Children's Hospital

Jena, 7745, Germany

RECRUITING

University Children's Hospital

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Study Officials

  • Peter Lang, MD

    University Children's Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lang, MD

CONTACT

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

Rupert Handgretinger, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 9, 2013

Study Start

March 1, 2004

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

AU(1)DE(4)