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Cord Blood Transplantation in Severe Aplastic Anemia (APCORD)

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ClinicalTrials.gov Identifier: NCT01343953
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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;

Condition or disease Intervention/treatment Phase
Hereditary Diseases Acquired Aplastic Anemia Relapse Absence of an HLA Identical Donor Procedure: Cord Blood Transplantation Phase 2

Detailed Description:
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse After Immunosuppressive Therapy
Study Start Date : May 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cord Blood Transplantation 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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Graft versus host disease [ Time Frame: 2 years ]
  2. Infectious episodes [ Time Frame: 1 year ]
  3. treatment related mortality [ Time Frame: 100 days ]
  4. overall survival [ Time Frame: 5 years ]
  5. adverse events [ Time Frame: 1 year ]
  6. karnofsky scale [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01343953


Locations
France
saint Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Regis Peffault de la Tour, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01343953     History of Changes
Other Study ID Numbers: P090201
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
severe aplastic anemia
cord blood transplantation

Additional relevant MeSH terms:
Anemia
Recurrence
Anemia, Aplastic
Genetic Diseases, Inborn
 Hematologic Diseases
Disease Attributes
Pathologic Processes
Bone Marrow Diseases