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New York Blood Center National Cord Blood Program

Primary Purpose

Leukemia, Lymphoma, Genetic Disease

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Umbilical Cord Blood Transplantation
Sponsored by
New York Blood Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Cord blood transplantation, bone marrow transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Candidates for bone marrow transplantation Exclusion Criteria: -

Sites / Locations

  • New York Blood Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Umbilical cord blood unit(s) transplant

Arm Description

Transplantation of cryopreserved umbilical cord blood unit(s)

Outcomes

Primary Outcome Measures

Engraftment
Treatment Related Mortality
Survival

Secondary Outcome Measures

Graft vs. Host Disease
Relapse

Full Information

First Posted
September 13, 2005
Last Updated
October 31, 2018
Sponsor
New York Blood Center
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1. Study Identification

Unique Protocol Identification Number
NCT00212407
Brief Title
New York Blood Center National Cord Blood Program
Official Title
New York Blood Center National Cord Blood Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Study NCT01656603 supersedes this study; FDA IND 6637
Study Start Date
February 1993 (undefined)
Primary Completion Date
November 10, 2011 (Actual)
Study Completion Date
November 10, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Blood Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Genetic Disease, Severe Aplastic Anemia, Myelodysplasia
Keywords
Cord blood transplantation, bone marrow transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical cord blood unit(s) transplant
Arm Type
Experimental
Arm Description
Transplantation of cryopreserved umbilical cord blood unit(s)
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood Transplantation
Other Intervention Name(s)
One or more matched umbilical cord blood units for transplant
Primary Outcome Measure Information:
Title
Engraftment
Time Frame
released prior to 12-1-2012
Title
Treatment Related Mortality
Time Frame
released prior to 12-1-2012
Title
Survival
Time Frame
released prior to 12-1-2012
Secondary Outcome Measure Information:
Title
Graft vs. Host Disease
Time Frame
released prior to 12-1-2012
Title
Relapse
Time Frame
released prior to 12-1-2012

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Candidates for bone marrow transplantation Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Rubinstein, M.D.
Organizational Affiliation
New York Blood Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Blood Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nationalcordbloodprogram.org
Description
Click here for more information about the New York Blood Center National Cord Blood Program

Learn more about this trial

New York Blood Center National Cord Blood Program

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