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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 August 2017 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 10, 2017
Last verified: August 2017
May 9, 2011
August 10, 2017
October 2011
October 2021   (Final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01351545 on ClinicalTrials.gov Archive Site
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Not Provided
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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 objective 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 overall 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
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.
  • Hematologic Malignancies
  • Inherited Disorders of Metabolism
  • Inherited Abnormalities of Platelets
  • Histiocytic Disorders
  • Acute Myelogenous Leukemia (AML or ANLL)
  • Acute Lymphoblastic Leukemia (ALL)
  • Other Acute Leukemia
  • Chronic Myelogenous Leukemia (CML)
  • Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
  • Other Leukemia
  • Hodgkin Lymphoma
  • Non-hodgkin Lymphoma
  • Multiple Myeloma/ Plasma Cell Disorder (PCD)
  • Inherited Abnormalities of Erythrocyte Differentiation or Function
  • Disorders of the Immune System
  • Automimmune Diseases
  • Severe Aplastic Anemia
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
99999
Not Provided
October 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
  • Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
  • Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Lexi Adams, MPH, CCRP 763-406-8735 aadams@nmdp.org
Contact: Michael Tierney mtierney@nmdp.org
United States
 
 
NCT01351545
10-CBA
Yes
Not Provided
Not Provided
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 2017

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