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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hereditary Diseases Acquired Aplastic Anemia Relapse Absence of an HLA Identical Donor | Procedure: Cord Blood Transplantation | Phase 2 |
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 |
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
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- Overall survival [ Time Frame: 1 year ]
- Graft versus host disease [ Time Frame: 2 years ]
- Infectious episodes [ Time Frame: 1 year ]
- treatment related mortality [ Time Frame: 100 days ]
- overall survival [ Time Frame: 5 years ]
- adverse events [ Time Frame: 1 year ]
- karnofsky scale [ Time Frame: 1 year ]

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

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
France | |
saint Louis | |
Paris, France, 75010 |
Principal Investigator: | Regis Peffault de la Tour, MD, PhD | Assistance Publique - Hôpitaux de Paris |
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 |