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Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies

Primary Purpose

Hematologic Malignancies

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Fludarabine
Thiotepa
Melphalan
OKT-3
CD3/CD19 depletion on CliniMACS
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancies focused on measuring haploidentical transplantation, immunomagnetic cell sorting, allogeneic hematopoietic cell transplantation, dose reduced conditioning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age <60, >18 years Karnofsky >60% High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with: ALL AML PNH MDS (RAEB-t/secondary AML) NHL ALL HD CML MM No HLA-identical MRD or URD if not preceding allo-HCT Use haploidentical donor with KIR-Mismatch if choice Exclusion Criteria: < 3 months after preceding HCT Active cerebral seizures > 30% blasts in BM if ALL/AML/CML-BC Completely chemo-refractory Preceding myocardial infarction Ejection fraction <30 % echocardiography Creatinine clearance <50 ml/min Respiratory insufficiency on supplemental O2 or DLCO < 30% Allergy against murine antibodies HIV infection Pregnancy Unable for informed consent

Sites / Locations

  • University of Dresden Medical Center
  • Center for Marrow Transplantation
  • Medical Center University of Hamburg
  • Medical Center University of Muenster
  • South West German Cancer Center, University of Tuebingen Medical Center
  • Deutsche Klinik für Diagnostik
  • University of Wuerzburg Medical Center

Outcomes

Primary Outcome Measures

Engraftment
Toxicity
Mortality and Morbidity

Secondary Outcome Measures

Infections
GVHD
Immune reconstitution
Disease response
Long term toxicity

Full Information

First Posted
September 12, 2005
Last Updated
May 28, 2014
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00202917
Brief Title
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
Official Title
Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.
Detailed Description
Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
haploidentical transplantation, immunomagnetic cell sorting, allogeneic hematopoietic cell transplantation, dose reduced conditioning

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
61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Type
Drug
Intervention Name(s)
OKT-3
Intervention Type
Procedure
Intervention Name(s)
CD3/CD19 depletion on CliniMACS
Primary Outcome Measure Information:
Title
Engraftment
Title
Toxicity
Title
Mortality and Morbidity
Secondary Outcome Measure Information:
Title
Infections
Title
GVHD
Title
Immune reconstitution
Title
Disease response
Title
Long term toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age <60, >18 years Karnofsky >60% High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with: ALL AML PNH MDS (RAEB-t/secondary AML) NHL ALL HD CML MM No HLA-identical MRD or URD if not preceding allo-HCT Use haploidentical donor with KIR-Mismatch if choice Exclusion Criteria: < 3 months after preceding HCT Active cerebral seizures > 30% blasts in BM if ALL/AML/CML-BC Completely chemo-refractory Preceding myocardial infarction Ejection fraction <30 % echocardiography Creatinine clearance <50 ml/min Respiratory insufficiency on supplemental O2 or DLCO < 30% Allergy against murine antibodies HIV infection Pregnancy Unable for informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang A Bethge, MD
Organizational Affiliation
University of Tuebingen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dresden Medical Center
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Center for Marrow Transplantation
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Medical Center University of Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medical Center University of Muenster
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
South West German Cancer Center, University of Tuebingen Medical Center
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
University of Wuerzburg Medical Center
City
Wuerzburg
ZIP/Postal Code
D-97070
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22491731
Citation
Federmann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4.
Results Reference
derived
Links:
URL
http://www.onkologie-tuebingen.de
Description
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Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies

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