Cord Blood Transplantation in Severe Aplastic Anemia

Relapse Clinical Trial

— APCORD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343953
• Other study ID #: P090201
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2011
• Last updated: June 13, 2017
• Start date: May 2011
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Absence of an HLA Identical Donor
• Acquired Aplastic Anemia
• Anemia
• Anemia, Aplastic
• Genetic Diseases, Inborn
• Hereditary Diseases
• Recurrence
• Relapse

Intervention

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

Locations

Country	Name	City	State
France	saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1 year
Secondary	Graft versus host disease		2 years
Secondary	Infectious episodes		1 year
Secondary	treatment related mortality		100 days
Secondary	overall survival		5 years
Secondary	adverse events		1 year
Secondary	karnofsky scale		1 year