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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202917
First Posted: September 20, 2005
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  Purpose
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.

Condition Intervention Phase
Hematologic Malignancies Drug: Fludarabine Drug: Thiotepa Drug: Melphalan Drug: OKT-3 Procedure: CD3/CD19 depletion on CliniMACS Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 University Hospital Tuebingen:

Primary Outcome Measures:
  • Engraftment
  • Toxicity
  • Mortality and Morbidity

Secondary Outcome Measures:
  • Infections
  • GVHD
  • Immune reconstitution
  • Disease response
  • Long term toxicity

Enrollment: 61
Study Start Date: February 2004
Study Completion Date: December 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202917


Locations
Germany
University of Dresden Medical Center
Dresden, Germany, D-01307
Center for Marrow Transplantation
Essen, Germany, 45122
Medical Center University of Hamburg
Hamburg, Germany, 20246
Medical Center University of Muenster
Muenster, Germany, 48129
South West German Cancer Center, University of Tuebingen Medical Center
Tuebingen, Germany, 72076
Deutsche Klinik für Diagnostik
Wiesbaden, Germany, 65191
University of Wuerzburg Medical Center
Wuerzburg, Germany, D-97070
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Wolfgang A Bethge, MD University of Tuebingen Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00202917     History of Changes
Other Study ID Numbers: E203/2004
IRB Project Nr. 21/2004
HSZ-001
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by University Hospital Tuebingen:
haploidentical transplantation
immunomagnetic cell sorting
allogeneic hematopoietic cell transplantation
dose reduced conditioning

Additional relevant MeSH terms:
Neoplasms
Fludarabine
Melphalan
Thiotepa
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs