Clinical trial NCT00212407: New York Blood Center National Cord Blood Program
Official title: New York Blood Center National Cord Blood Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Leukemia
Lymphoma
Genetic Disease
Severe Aplastic Anemia
Myelodysplasia
Keywords: Cord blood transplantation
bone marrow transplantation
Lead sponsor: New York Blood Center
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 4476
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Candidates for bone marrow transplantation

Exclusion Criteria:

-

Primary outcomes:
measure: Engraftment
timeFrame: released prior to 12-1-2012
measure: Treatment Related Mortality
timeFrame: released prior to 12-1-2012
measure: Survival
timeFrame: released prior to 12-1-2012
Secondary outcomes:
measure: Graft vs. Host Disease
timeFrame: released prior to 12-1-2012
measure: Relapse
timeFrame: released prior to 12-1-2012
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Blood Center
state: New York
Study officials:
affiliation: New York Blood Center
name: Pablo Rubinstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: