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Trial record 1 of 1 for:    NCT01351545
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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 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: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
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)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Center for International Blood and Marrow Transplant Research:

Estimated Enrollment: 99999
Study Start Date: October 2011
Groups/Cohorts Assigned Interventions
Unlicensed CBU
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
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

Detailed Description:

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351545

Contacts
Contact: Lexi Adams 612-884-8735 aadams@nmdp.org
Contact: Mandi Proue 612-617-8395 mproue@nmdp.org

  Show 136 Study Locations
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
Study Chair: John Miller, MD, PhD NMDP/CIBMTR
  More Information

No publications provided

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01351545     History of Changes
Other Study ID Numbers: 10-CBA
Study First Received: May 9, 2011
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adrenoleukodystrophy
Beta-Thalassemia
Congenital Abnormalities
Disease
Immunologic Deficiency Syndromes
Neoplasms
Pancytopenia
Thalassemia
Adrenal Gland Diseases
Adrenal Insufficiency
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Demyelinating Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemoglobinopathies
Hereditary Central Nervous System Demyelinating Diseases
Heredodegenerative Disorders, Nervous System
Immune System Diseases
Intellectual Disability
Leukoencephalopathies
Mental Retardation, X-Linked
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014