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

March 14, 2024 updated by: Center for International Blood and Marrow Transplant Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

99999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Joseph Chewning, MD
    • Arizona
      • Gilbert, Arizona, United States, 85234
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
        • Principal Investigator:
          • Roberta Adams, MD
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona (adults)
        • Contact:
        • Principal Investigator:
          • James Slack, MD
      • Tucson, Arizona, United States, 85224
        • Recruiting
        • University of Arizona Medical Center - Tucson
        • Contact:
        • Principal Investigator:
          • Emmanuel Katsanis, MD
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Monzr Al Malki, MD
      • Glendale, California, United States, 91204
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
        • Principal Investigator:
          • Neena Kapoor, MD
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • Edward Ball, MD
      • La Jolla, California, United States, 92037
      • Loma Linda, California, United States, 92350
        • Recruiting
        • Loma Linda University Cancer Center
        • Contact:
        • Principal Investigator:
          • Hisham Abdel-Azim, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Contact:
        • Principal Investigator:
          • Gary Schiller, MD
      • Oakland, California, United States, 94609
        • Recruiting
        • Children's Hospital and Research Center of Oakland
        • Contact:
        • Principal Investigator:
          • Mark Walters, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County (CHOC)
        • Contact:
        • Principal Investigator:
          • Rishikesh Chavan, MD
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Carroll, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital San Diego
        • Contact:
        • Principal Investigator:
          • Eric Anderson, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF (adults)
        • Contact:
        • Principal Investigator:
          • Thomas Martin, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF (peds)
        • Contact:
        • Principal Investigator:
          • Sandhya Kharbanda, MD
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • Andrew Rezvani, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan Gutman, MD
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Michael Verneris, MD
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian St. Luke's/Colorado Blood Cancer Institute
        • Contact:
        • Principal Investigator:
          • Alireza Eghtedar, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Contact:
        • Principal Investigator:
          • Aaron Flagg, MD
    • Delaware
      • Brandywine, Delaware, United States, 19803
        • Recruiting
        • Nemours - Alfred I. duPont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Emi Caywood, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
        • Principal Investigator:
          • David Jacobsohn, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Shands Medical Center
        • Contact:
        • Principal Investigator:
          • John R Wingard, MD
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic - Jacksonville
        • Contact:
        • Principal Investigator:
          • Vivek Roy, MD
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Hospital - Mayo Jacksonville
        • Contact:
        • Principal Investigator:
          • Michael Joyce, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami (adult)
        • Contact:
          • Denise Pereira, MD
          • Phone Number: 305-243-1000
        • Principal Investigator:
          • Denise Pereira, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami (peds)
        • Contact:
        • Principal Investigator:
          • Edward Ziga, MD, MPH
      • Miami, Florida, United States, 33155
      • Orlando, Florida, United States, 32804
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Florida Center for Pediatric Cellular Therapy
        • Contact:
        • Principal Investigator:
          • Susan Kelly, MD
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • Orlando Health Bone Marrow Transplant and Cellular Therapy
        • Contact:
        • Principal Investigator:
          • Yasser Khaled, MD
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Deepakbabu Chellapandian, MD
      • Tampa, Florida, United States, 33612
        • Terminated
        • H Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
        • Principal Investigator:
          • Scott Solomon, MD
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Ann Haight, MD
      • Atlanta, Georgia, United States, 30322
        • Terminated
        • Emory University Hospital
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Medical College of Georgia
        • Contact:
        • Principal Investigator:
          • Claude Sportes, MD
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
        • Principal Investigator:
          • Randal Wada, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Sunita Nathan, MD
        • Principal Investigator:
          • Sunita Nathan, MD
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • James LaBelle, MD, PhD
        • Contact:
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • Damiano Rondelli, MD
      • Chicago, Illinois, United States, 60614
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Sonali Chaudhury, MD
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
        • Principal Investigator:
          • Patrick Stiff, MD
      • Park Ridge, Illinois, United States, 60068
        • Terminated
        • Advocate Lutheran General Hospital
      • Zion, Illinois, United States, 60099
        • Terminated
        • Midwestern Regional Medical Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Recruiting
        • Indiana Blood & Marrow Transplantation
        • Contact:
        • Principal Investigator:
          • Luke Akard, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Riley Hospital for Children
        • Contact:
        • Principal Investigator:
          • Sherif Farag, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Margarida Silverman, MD
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas
        • Contact:
        • Principal Investigator:
          • Joseph McGuirk, DO
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Hospital - James Brown Cancer Center
        • Contact:
        • Principal Investigator:
          • William Tse, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Medical Center
        • Contact:
        • Principal Investigator:
          • Hana Safa, MD
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital of New Orleans/LSUHSC
        • Contact:
        • Principal Investigator:
          • Lolie Yu, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Contact:
        • Principal Investigator:
          • Allen Chen, MD, PhD
      • Baltimore, Maryland, United States, 21201
        • Withdrawn
        • Greenebaum Cancer Center - University of Maryland
      • Bethesda, Maryland, United States, 20892-1456
        • Recruiting
        • Nih/Niaid
        • Contact:
        • Principal Investigator:
          • Elizabeth Kang, MD
      • Bethesda, Maryland, United States, 20892
        • Terminated
        • NIH/NCI
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • Nih/Nhlbi
        • Contact:
        • Principal Investigator:
          • Richard Childs, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Cory Cutler, MD
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Andreas Klein, MD
      • Boston, Massachusetts, United States, 02114
        • Suspended
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Suspended
        • Beth Israel Deaconess
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Contact:
        • Principal Investigator:
          • Jan Cerny, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Gregory Yanik, M.D.
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Nalini Janakiraman, MD
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
        • Contact:
        • Principal Investigator:
          • Sureyya Savasan, MD
      • Detroit, Michigan, United States, 48201
        • Suspended
        • Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids, Michigan, United States, 49503
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
        • Principal Investigator:
          • William Hogan, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Univeristy of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Carolyn Bigelow, MD
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Suspended
        • Children's Mercy Hospital and Clinics
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • Cardinal Glennon Children's Medical Center
        • Contact:
        • Principal Investigator:
          • Deepika Bhatla, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis University Medical Center
        • Contact:
        • Principal Investigator:
          • Sagun Goyal, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University St. Louis
        • Contact:
        • Principal Investigator:
          • Geoffrey Uy, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University/St. Louis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Geoffrey Uy, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2168
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Phyllis Warkenton, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
        • Principal Investigator:
          • Alfred Gillio, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson/Cancer Institute of New Jersey
        • Contact:
        • Principal Investigator:
          • Matthew Matasar, MD, MS
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Children's Hospital at Montefiore
        • Contact:
        • Principal Investigator:
          • David Loeb, MD, PhD
      • Buffalo, New York, United States, 14263
      • Lake Success, New York, United States, 11042
        • Recruiting
        • North Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Ruthee L Bayer, MD
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Cohen Children's Medical Center of New York
        • Contact:
        • Principal Investigator:
          • Jonathan Fish, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Alla Keyzner, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Ioannis Politikos, MD
      • New York, New York, United States, 10016
      • New York, New York, United States, 10021
        • Recruiting
        • New York Presbyterian Hospital at Cornell
        • Principal Investigator:
          • Tsiporah Shore, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center - Morgan Stanley Children's Hospital
        • Contact:
        • Principal Investigator:
          • Monica Bhatia, MD
      • New York, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Principal Investigator:
          • Mitchell Cairo, MD
        • Contact:
      • Rochester, New York, United States, 14642-8704
        • Recruiting
        • Strong Memorial Hospital/University of Rochester
        • Contact:
        • Principal Investigator:
          • Omar Aljitawi, MD
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Hospital
        • Contact:
        • Principal Investigator:
          • Michael Schuster, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Kimberly Kasow, DO
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Joanne Kurtzberg, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Withdrawn
        • Wake Forest University
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Childrens Hospital Medical Center of Akron
        • Principal Investigator:
          • Megan Sampson, MD
        • Contact:
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Contact:
        • Principal Investigator:
          • Stella Davies, MD
      • Cincinnati, Ohio, United States, 45230
        • Withdrawn
        • The Jewish Hospital
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Case Medical Center
        • Contact:
        • Principal Investigator:
          • Hillard Lazarus, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Craig Sauter, MD
      • Columbus, Ohio, United States, 43205
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Arthur G. James Cancer Hospital/The Ohio State University Medical Center
        • Contact:
        • Principal Investigator:
          • Sumithira Vasu, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Recruiting
        • University of Oklahoma Health Science Center
        • Contact:
        • Principal Investigator:
          • Adam Asch, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University/Doernbecher Children's Hospital
        • Contact:
        • Principal Investigator:
          • Eneida Nemecek, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Cancer Center
        • Contact:
        • Principal Investigator:
          • Shin Mineishi, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Nancy Bunin, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Paul Szabolcs, MD
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Alison Sehgal, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Western Penn Hospital
        • Contact:
        • Principal Investigator:
          • John Lister, MD
      • Pittsburgh, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Thomas Jefferson
        • Contact:
        • Principal Investigator:
          • Elizabeth Hexner, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Recruiting
        • Roger Williams Medical Center
        • Contact:
        • Principal Investigator:
          • Todd Roberts, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Michelle Hudspeth, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Transplant Institute
        • Contact:
        • Principal Investigator:
          • Waqas Jehangir, MD, FACP
    • Tennessee
      • Memphis, Tennessee, United States, 38104
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Childrens Research Hospital
        • Contact:
        • Principal Investigator:
          • Renee Madden, MD
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Michael Byrne, MD
      • Nashville, Tennessee, United States, 37212
        • Withdrawn
        • VA Tennessee Valley Healthcare System
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Amarillo, Texas, United States, 79106
        • Terminated
        • Amarillo Blood and Marrow Transplant Program
      • Dallas, Texas, United States, 75235
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75390
        • Withdrawn
        • University of Texas Southwestern Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • Recruiting
        • Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)
        • Contact:
        • Principal Investigator:
          • Lauren Lee, MD
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • M.D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth Shpall, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital - Baylor Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Krance, MD
      • Lubbock, Texas, United States, 79415
        • Withdrawn
        • Southwest Cancer Treatment & Research Center
      • San Antonio, Texas, United States, 78207
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Healthcare System of San Antonio/Texas Transplant Institute
        • Contact:
        • Principal Investigator:
          • Jose Cruz, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Ahmad Rayes, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Richmond, Virginia, United States, 23227
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • John McCarty, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Contact:
        • Principal Investigator:
          • Ann Dahlberg, MD
      • Seattle, Washington, United States, 98108
        • Suspended
        • VA Puget Sound HCS
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-8110
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Lauren Veltri, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin - Madison
        • Principal Investigator:
          • Kenneth DeSantes, MD
        • Contact:
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
        • Principal Investigator:
          • David Margolis, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Mehdi Hamadani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
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.
Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for International Blood and Marrow Transplant Research

Collaborators

National Marrow Donor Program

Investigators

  • Study Chair: John Miller, MD, PhD, NMDP/CIBMTR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Estimated)

October 1, 2041

Study Completion (Estimated)

October 1, 2041

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimated)

May 11, 2011

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-CBA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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