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Autologous Hematopoietic Stem Cell Transplantation for Refractory Autoimmune Diseases (ASTRAD)

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.
 
ClinicalTrials.gov Identifier: NCT00742300
Recruitment Status : Unknown
Verified November 2008 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2008
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE August 26, 2008
First Posted Date  ICMJE August 27, 2008
Last Update Posted Date November 24, 2008
Study Start Date  ICMJE January 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2008)
  • Disease-free survival [ Time Frame: 24 months ]
  • Overall Survival [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2008)
  • Immune Reconstitution [ Time Frame: over 24 months ]
  • Organ-specific response parameters [ Time Frame: 24 months ]
  • Serological Response (Autoantibodies) [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Hematopoietic Stem Cell Transplantation for Refractory Autoimmune Diseases
Official Title  ICMJE Phase I/II Open-Label Monocentric Clinical Trial for Induction of Tolerance With CD34-Enriched Autologous Hematopoietic Stem Cell Transplantation After High-Dose Chemotherapy With Cyclophosphamide and Rabbit-Antithymocyte Globulin for Refractory Autoimmune Diseases
Brief Summary While glucocorticoids and immunosuppressants ameliorate manifestations of autoimmune diseases in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical prognosis remains poor due to the development of vital organ failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation (ASCT) has recently emerged as a promising experimental therapy for severely affected patients, providing them the potential to achieve treatment-free, long-term remission. The rationale for applying ASCT to autoimmune diseases has been the hope that immunoablation could eliminate inflammation-driving pathogenic cells from the immune system, and that regeneration of the patients' immune system from hematopoietic precursors could re-establish immunological tolerance.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Diseases
Intervention  ICMJE Procedure: Autologous hematopoietic stem cell transplantation
Transplantation of CD34-selected autologous hematopoietic stem cells after high-dose chemotherapy with cyclophosphamide (200mg/kg) and rabbit-antithymocyteglobulin (90mg/kg)
Other Names:
  • Mobilization: 2.0 g/m2 Cyclophosphamide followed by daily G-CSF (10 µg/kg, Amgen, Thousand Oaks, CA)
  • Conditioning: 200mg/kg Cyclophosphamide (Endoxan), 90mg/kg rabbit-antithymocyteglobulin (ATG, Fresenius, Bad Homburg, Germany)
  • Stem cell selection: CliniMACS Device (Miltenyi Biotec, Bergisch Gladbach, Germany)
Study Arms  ICMJE Experimental: A
Treatment Group
Intervention: Procedure: Autologous hematopoietic stem cell transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Autoimmune disease
  • Active disease with inadequate response to standard protocols (glucocorticoids and at least two different regimens of immunosuppressive drugs, such as intravenous cyclophosphamide 800-1000mg/application)
  • Provision of informed consent by subject

Exclusion Criteria:

  • Active or chronic infections
  • Uncontrolled arrhythmia or congestive heart failure (ejection fraction below 50% determined by echocardiogram)
  • Lung fibrosis (transfer factor for carbon monoxide [TLCO] <45%)
  • renal insufficiency (glomerular filtration rate below 40 ml/min)
  • Pulmonary arterial hypertension (>40mmHg)
  • History of malignancy
  • Women who are pregnant or breastfeeding
  • Use non-reliable methods of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00742300
Other Study ID Numbers  ICMJE CT-0198
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Christoph Krukenkamp, Charité Universitätsmedizin Berlin
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Charite University, Berlin, Germany
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Renate Arnold, Prof. Dr. med. Charite University, Berlin, Germany
Study Chair: Falk Hiepe, Prof. Dr. med. Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP