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

This study is currently recruiting participants.

Verified by South West German Cancer Center, May 2008

Sponsored by:	South West German Cancer Center
Information provided by:	South West German Cancer Center
ClinicalTrials.gov Identifier:	NCT00202917

Purpose

Feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.

Condition	Intervention	Phase
Hematologic Malignancies	Drug: Fludarabine Drug: Thiotepa Drug: Melphalan Drug: OKT-3 Procedure: CD3/CD19 depletion on CliniMACS	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Melphalan Thiotepa Fludarabine Fludarabine monophosphate Melphalan hydrochloride Sarcolysin Muromonab CD3

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies

Further study details as provided by South West German Cancer Center:

Primary Outcome Measures:

Engraftment
Toxicity
Mortality and Morbidity

Secondary Outcome Measures:

Infections
GVHD
Immune reconstitution
Disease response
Long term toxicity

Estimated Enrollment:	40
Study Start Date:	February 2004
Estimated Study Completion Date:	February 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202917

Contacts

Contact: Wolfgang A Bethge, MD

49-07071-298-3176

wolfgang.bethge@med.uni-tuebingen.de

Locations

Germany
South West German Cancer Center, University of Tuebingen Medical Center	Recruiting
Tuebingen, Germany, 72076
Contact: Wolfgang A Bethge, MD 49-7071-298-3176 wolfgang.bethge@med.uni-tuebingen.de
Contact: Christoph Faul, MD 49-7071-298-4087 christoph.faul@med.uni-tuebingen.de
Principal Investigator: Wolfgang A Bethge, MD
University of Dresden Medical Center	Recruiting
Dresden, Germany, D-01307
Contact: Martin Bornhaeuser, MD 49-351-458-4186 bornhaeuser@mk1.med.tu-dresden.de
University of Wuerzburg Medical Center	Recruiting
Wuerzburg, Germany, D-97070
Contact: Hermann Einsele, MD 49-931-2017-0012
Deutsche Klinik für Diagnostik	Recruiting
Wiesbaden, Germany, 65191
Contact: Rainer Schwerdtfeger, MD kmt@dkd-wiesbaden.de
Medical Center University of Muenster	Recruiting
Muenster, Germany, 48129
Contact: E. Berdel, MD berdel@uni-muenster.de
Medical Center University of Hamburg	Recruiting
Hamburg, Germany, 20246
Contact: Nikolaus Kroeger, MD nkroeger@uke.uni-hamburg.de
Center for Marrow Transplantation	Recruiting
Essen, Germany, 45122
Contact: Dietrich Beelen, MD dietrich.beelen@uni-essen.de

Sponsors and Collaborators

South West German Cancer Center

Investigators

Principal Investigator:

Wolfgang A Bethge, MD

University of Tuebingen Medical Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	E203/2004, IRB Project Nr. 21/2004, HSZ-001
Study First Received:	September 12, 2005
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00202917
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by South West German Cancer Center:

haploidentical transplantation
immunomagnetic cell sorting
allogeneic hematopoietic cell transplantation
dose reduced conditioning

Study placed in the following topic categories:

Melphalan
Hematologic Neoplasms
Hematologic Diseases
Fludarabine

Fludarabine monophosphate
Muromonab-CD3
Thiotepa

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009