New York Blood Center National Cord Blood Program

Lymphoma Clinical Trial

Official title:

New York Blood Center National Cord Blood Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00212407
• Other study ID #: 234
• Status: Terminated
• Phase: Early Phase 1
• Start date: February 1993
• Est. completion date: November 10, 2011

Study information

• Verified date: October 2018
• Source: New York Blood Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

Description:

Umbilical cord blood donated to the New York Blood Center's National Cord Blood Program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health.

Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. Most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases.

Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs. Because the NYBC Program operates under IND, patients must sign an informed consent for cord blood transplantation.

Transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. Data report to the New York Blood Center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4476
• Est. completion date: November 10, 2011
• Est. primary completion date: November 10, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Candidates for bone marrow transplantation

Exclusion Criteria:

Related Conditions & MeSH terms

• Anemia, Aplastic
• Genetic Disease
• Genetic Diseases, Inborn
• Leukemia
• Lymphoma
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia
• Severe Aplastic Anemia

Intervention

Biological:
• Umbilical Cord Blood Transplantation

Locations

Country	Name	City	State
United States	New York Blood Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment		released prior to 12-1-2012
Primary	Treatment Related Mortality		released prior to 12-1-2012
Primary	Survival		released prior to 12-1-2012
Secondary	Graft vs. Host Disease		released prior to 12-1-2012
Secondary	Relapse		released prior to 12-1-2012

External Links

•   Click here for more information about the New York Blood Center National Cord Blood Program