A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications
Sponsor study identifier
Secondary identifiers
interventional
0
0 countries
N/A
Study Start
October 27, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 26, 2012
Actual (reported)Study Completion
November 26, 2012
Actual (reported)Background: \- Cord blood banks have been set up to collect and store umbilical cord blood for transplants. These transplants are used to treat different types of cancer. In October 2011, the Food and Drug Administration (FDA) began considering cord blood as a biological drug. Most of the cord blood units currently available in cord blood banks in the United States and other countries were collected before the FDA set these new standards. The units meet standards set by the National Marrow Donor Program (NMDP), but they were not collected, tested, or stored exactly according to FDA standards. As a result, the new guidelines state that they may only be used for transplant if the transplant is done as part of a study. Researchers have set up a study to provide these cord blood units to recipients and to study the effects of their use. Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 26, 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 22, 2011
Actual (reported)November 24, 2011
Actual (reported)November 26, 2012
Actual (reported)November 26, 2012
Actual (reported)The primary aim of this study is to examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licen...
Assess incidence of graft rejection.
Assess incidence of transmission of infection.
Assess incidence of serious infusion reaction.
Determine 1 year survival after cord blood transplantation.
Assess cumulative incidence of aGVHD vs cGVHD.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Laughlin MJ, Barker J, Bambach B, Koc ON, Rizzieri DA, Wagner JE, Gerson SL, Lazarus HM, Cairo M, Stevens CE, Rubinstein P, Kurtzberg J. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001 Jun 14;344(24):1815-22. doi: 10.1056/NEJM200106143442402.
Kurtzberg J, Laughlin M, Graham ML, Smith C, Olson JF, Halperin EC, Ciocci G, Carrier C, Stevens CE, Rubinstein P. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. N Engl J Med. 1996 Jul 18;335(3):157-66. doi: 10.1056/NEJM199607183350303.
Ronald E Gress, M.D.
National Cancer Institute (NCI)
0 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2011
First Posted
November 24, 2011
Study Start
October 27, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Imaging Studies and the Development of Multiple Myeloma
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Rocha V, Labopin M, Sanz G, Arcese W, Schwerdtfeger R, Bosi A, Jacobsen N, Ruutu T, de Lima M, Finke J, Frassoni F, Gluckman E; Acute Leukemia Working Party of European Blood and Marrow Transplant Group; Eurocord-Netcord Registry. Transplants of umbilical-cord blood or bone marrow from unrelated donors in adults with acute leukemia. N Engl J Med. 2004 Nov 25;351(22):2276-85. doi: 10.1056/NEJMoa041469.
Primary Completion
November 26, 2012
Actual (reported)Study Completion
November 26, 2012
Actual (reported)Last Updated
December 21, 2018
Record last verified: 2012-11-26
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Source: ClinicalTrials.gov.
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