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NCT Number: NCT01343953

Cord Blood Transplantation in Severe Aplastic Anemia

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;

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Key information

Conditions

Hereditary Diseases Absence of an HLA Identical Donor Acquired Aplastic Anemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Relapse

Age range

3 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

saint Louis

Paris, 75010, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cord blood transplantation

Procedure

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

Primary outcomes

  1. Overall survival

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: APCORD

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2011
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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