A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01351545
First received: May 9, 2011
Last updated: August 13, 2014
Last verified: August 2014

May 9, 2011
August 13, 2014
October 2011
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Complete list of historical versions of study NCT01351545 on ClinicalTrials.gov Archive Site
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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

Study Design:

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Primary Objective:

The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

  • Assess incidence of transmission of infection
  • Assess incidence of serious infusion reaction
  • Determine 1 year survival after cord blood transplantation
  • Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
  • Assess cumulative incidence of chronic GVHD
  • Determine platelet engraftment of >20,000 mcL and >50,000 mcL
Observational
Time Perspective: Prospective
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Non-Probability Sample

Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.

  • Hematologic Malignancies
  • Certain:
  • Inherited Disorders of Metabolism
  • Inherited Abnormalities of Erythrocyte Differentiation or Function
  • Inherited Abnormalities of Platelets
  • Disorders of the Immune System
  • Histiocytic Disorders
  • X-linked Adrenoleukodystrophy
  • Primary Immunodeficiency Diseases
  • Bone Marrow Failure
  • Beta-thalassemia
Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
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
Unlicensed CBU
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
Intervention: Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
99999
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Inclusion Criteria:

  • Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Signed informed consent (and signed assent, if applicable)
  • Pediatric and adult patients of any age

Exclusion Criteria:

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
Both
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No
Contact: Lexi Adams 612-884-8735 aadams@nmdp.org
Contact: Mandi Proue 612-617-8395 mproue@nmdp.org
United States
 
NCT01351545
10-CBA
Yes
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Study Chair: John Miller, MD, PhD NMDP/CIBMTR
Center for International Blood and Marrow Transplant Research
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP