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Cord Blood Transplantation in Severe Aplastic Anemia (APCORD)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01343953
First received: April 27, 2011
Last updated: November 19, 2012
Last verified: November 2012
History of Changes

April 27, 2011
November 19, 2012
May 2011
May 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01343953 on ClinicalTrials.gov Archive Site
  • Graft versus host disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Infectious episodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • treatment related mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • karnofsky scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cord Blood Transplantation in Severe Aplastic Anemia
A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse After Immunosuppressive Therapy

This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an HLA identical donor;

This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an Human Leucocyte Antigen (HLA) identical donor; 26 patients will be recruited, according to a one step Fleming design
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hereditary Diseases
  • Acquired Aplastic Anemia
  • Relapse
  • Absence of an HLA Identical Donor
Procedure: Cord Blood Transplantation
One or 2 cord blood units containing alone or both together more than 4x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients for acquired Severe Aplastic Anemia
Other Name: Cord Blood Transplantation
Experimental: Cord Blood Transplantation
Intervention: Procedure: Cord Blood Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 3-55 years old
  • inherited aplastic anemia (with severe aplastic anemia criteria) or acquired aplastic anemia in relapse or treatment failure after immunosuppressive therapy without clonal evolution
  • Karnovsky Index >= 60%
  • Informed consent

Exclusion Criteria:

  • HLA identical donor
Both
3 Years to 55 Years
No
Contact: Regis Peffault de la Tour, MD, PhD 33(1)42385073 regis.peffaultdelatour@sls.aphp.fr
France
 
NCT01343953
P090201
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Regis Peffault de la Tour, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
November 2012

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