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

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ClinicalTrials.gov Identifier: NCT01351545
Recruitment Status : Recruiting
First Posted : May 11, 2011
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Tracking Information
First Submitted Date May 9, 2011
First Posted Date May 11, 2011
Last Update Posted Date April 29, 2021
Study Start Date October 2011
Estimated Primary Completion Date October 2041   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2021)
  • Neutrophil recovery of ≥500/mm3 after cord blood transplantation [ Time Frame: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant. ]
    The primary objective of this access and distribution protocol 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 FDA licensed.
  • Neutrophil recovery of ≥500/mm3 after cord blood transplantation [ Time Frame: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant. ]
    The primary objective of this access and distribution protocol 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 FDA licensed.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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
Brief Summary 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.
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
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.
Condition
  • 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
  • Autoimmune Diseases
  • Severe Aplastic Anemia
Intervention 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
Study Groups/Cohorts 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 10, 2011)
99999
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2041
Estimated Primary Completion Date October 2041   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Kelsey Schertz, MPH 763-406-4135 kschertz@nmdp.org
Contact: Danielle Rusnak 763-406-3400 drusnak@NMDP.ORG
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01351545
Other Study ID Numbers 10-CBA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Center for International Blood and Marrow Transplant Research
Study Sponsor Center for International Blood and Marrow Transplant Research
Collaborators National Marrow Donor Program
Investigators
Study Chair: John Miller, MD, PhD NMDP/CIBMTR
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date April 2021