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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 May 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: May 19, 2017
Last verified: May 2017
  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
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)

Study Type: Observational
Study Design: Observational Model: Other
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
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)
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 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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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) 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
  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, MPH, CCRP 763-406-8735 aadams@nmdp.org
Contact: Michael Tierney mtierney@nmdp.org

  Show 141 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

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: May 19, 2017

Additional relevant MeSH terms:
Lymphoma
Disease
Leukemia
Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Neoplasms
Lymphoma, Non-Hodgkin
Hodgkin Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Congenital Abnormalities
Leukemia, Myeloid, Acute
Anemia, Aplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Myeloproliferative Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 25, 2017