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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00202917
First received: September 12, 2005
Last updated: May 28, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by University Hospital Tuebingen

Additional 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
Study First Received: September 12, 2005
Last Updated: May 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Melphalan
Thiotepa
Fludarabine
Fludarabine phosphate
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on September 15, 2014