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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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Joseph Chewning, MD
jchewning@peds.uab.edu

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Contact:
September Mitchell, RN
september.mitchell@bannerhealth.com

Mayo Clinic Arizona (adults)
Phoenix, Arizona 85054
Contact:
James Slack, MD
slack.james@mayo.edu

University of Arizona Medical Center - Tucson
Tucson, Arizona 85224
Contact:
Emmanuel Katsanis, MD
katsanis@peds.arizona.edu

Arkansas Children's Hospital
Little Rock, Arkansas 72202
Contact:
Jason Farrar, MD
JEFarrar@uams.edu

City of Hope
Duarte, California 91010
Contact:
Monzr Al Malki, MD
malmalki@coh.org

Children's Hospital of Los Angeles
Glendale, California 91204
Contact:
Neena Kapoor, MD
nkapoor@chla.usc.edu

University of California San Diego
La Jolla, California 92093
Contact:
Edward Ball, MD
858-822-6600
tball@ucsd.edu

Scripps Green Hospital
LaJolla, California 92037
Contact:
Jeffrey W Andrey, MD
andrey.jeffrey@scrippshealth.org

Loma Linda University Cancer Center
Loma Linda, California 92350
Contact:
Hisham Abdel-Azim, MD
habdelazim@llu.edu

UCLA
Los Angeles, California 90095
Contact:
Gary Schiller, MD
310-206-5755
gschiller@mednet.ucla.edu

Children's Hospital and Research Center of Oakland
Oakland, California 94609
Contact:
Mark Walters, MD
mwalters@mail.cho.org

Children's Hospital of Orange County (CHOC)
Orange, California 92868
Contact:
Rishikesh Chavan, MD
rishikesh.chavan@choc.org

Sutter Medical Center
Sacramento, California 95816
Contact:
Michael Carroll, MD
carrolmp@sutterhealth.org

Rady Children's Hospital San Diego
San Diego, California 92123
Contact:
Eric Anderson, MD
eanderson@rchsd.org

Stanford University Medical Center
Stanford, California 94304
Contact:
Andrew Rezvani, MD
arezvani@stanford.edu

Children's Hospital Colorado
Aurora, Colorado 80045
Contact:
Michael Verneris, MD
MICHAEL.VERNERIS@CUANSCHUTZ.EDU

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Jonathan Gutman, MD
jonathan.gutman@ucdenver.edu

Presbyterian St. Luke's/Colorado Blood Cancer Institute
Denver, Colorado 80218
Contact:
Alireza Eghtedar, MD
alireza.eghtedar@healthonecares.com

Yale New Haven Hospital
New Haven, Connecticut 06510
Contact:
Aaron Flagg, MD
aron.flagg@yale.edu

Nemours - Alfred I. duPont Hospital for Children
Brandywine, Delaware 19803
Contact:
Emi Caywood, MD
ecaywood@nemours.org

Children's National Medical Center
Washington DC, District of Columbia 20010
Contact:
David Jacobsohn, MD
dajacobs@childrensnational.org

University of Florida Shands Medical Center
Gainesville, Florida 32610
Contact:
Jordan Milner, MD
352-273-9120
jordan.milner@ufl.edu

Nemours Children's Hospital - Mayo Jacksonville
Jacksonville, Florida 32207
Contact:
Michael Joyce, MD
mjoyce@nemours.org

Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
Contact:
Vivek Roy, MD
roy.vivek@mayo.edu

Niklaus Children's Hospital
Miami, Florida 33155
Contact:
Jorge Galvez-Silva, MD
jorgericardo.galvezsilva@nicklaushealth.org

AdventHealth Orlando
Orlando, Florida 32804
Contact:
Rushang Patel, MD
rushang.patel.md@adventhealth.com

Florida Center for Pediatric Cellular Therapy
Orlando, Florida 32804
Contact:
Susan Kelly, MD
susan.kelly.md@flhosp.org

All Children's Hospital
St. Petersburg, Florida 33701
Contact:
Deepakbabu Chellapandian, MD
dchella2@jhmi.edu

Children's Healthcare of Atlanta
Atlanta, Georgia 30322
Contact:
Ann Haight, MD
Ann.haight@choa.org

Northside Hospital
Atlanta, Georgia 30342
Contact:
Scott Solomon, MD
ssolomon@bmtga.com

Medical College of Georgia
Augusta, Georgia 30912
Contact:
Claude Sportes, MD
csportes@gru.edu

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96813
Contact:
Randal Wada, MD
randalw@hawaii.edu

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Kehinde Adekola, MD
kehinde-adekola@northwestern.edu

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Sunita Nathan, MD

University of Illinois at Chicago
Chicago, Illinois 60612
Contact:
Damiano Rondelli, MD
drond@uic.edu

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60614
Contact:
Sonali Chaudhury, MD
schaudhury@luriechildrens.org

University of Chicago
Chicago, Illinois 60637
Contact:
James LaBelle, MD, PhD
jlabelle@peds.bsd.uchicago.edu

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Patrick Stiff, MD
pstiff@lumc.edu

Indiana Blood & Marrow Transplantation
Beech Grove, Indiana 46107
Contact:
Luke Akard, MD
lakard@ibmtindy.com

Indiana University/Riley Hospital for Children
Indianapolis, Indiana 46202
Contact:
Jodi Skiles, MD
jskiles@iu.edu

University of Iowa
Iowa City, Iowa 52242
Contact:
Margarida Silverman, MD
margarida-silverman@uiowa.edu

University of Kansas
Westwood, Kansas 66205
Contact:
Joseph McGuirk, DO
jmcguirk@kumc.edu

University of Louisville Hospital - James Brown Cancer Center
Louisville, Kentucky 40202
Contact:
William Tse, MD
w0tse002@louisville.edu

Tulane Medical Center
New Orleans, Louisiana 70112
Contact:
Hana Safa, MD
hsafah@tulane.edu

Children's Hospital of New Orleans/LSUHSC
New Orleans, Louisiana 70118
Contact:
Lolie Yu, MD
(504) 896-9740
lyu@lsuhsc.edu

Johns Hopkins
Baltimore, Maryland 21287
Contact:
Allen Chen, MD, PhD
allenchen@jhmi.edu

Nih/Niaid
Bethesda, Maryland 20892-1456
Contact:
Elizabeth Kang, MD
ekang@niaid.nih.gov

Nih/Nhlbi
Bethesda, Maryland 20892
Contact:
Richard Childs, MD
childsr@nih.gov

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Andreas Klein, MD
617-636-8884
aklein2@tuftsmedicalcenter.org

Dana Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Corey Cutler, MD
cscutler@partners.org

University of Massachusetts
Worcester, Massachusetts 01655
Contact:
Jan Cerny, MD
Jan.Cerny@umassmemorial.org

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Jessica Yu
jjxyu@med.umich.edu

Children's Hospital of Michigan
Detroit, Michigan 48201
Contact:
Sureyya Savasan, MD
ssavasan@med.wayne.edu

Henry Ford Health System
Detroit, Michigan 48202
Contact:
Nalini Janakiraman, MD
njanaki1@hfhs.org

Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
Contact:
Troy Quigg, MD
troy.quigg@spectrumhealth.org

Spectrum Health
Grand Rapids, Michigan 49503
Contact:
Aly Abdel-Mageed, MD
aly.mageed@helendevoschildrens.org

Univeristy of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Carolyn Bigelow, MD
cbigelow@umc.edu

Cardinal Glennon Children's Medical Center
St. Louis, Missouri 63104
Contact:
Deepika Bhatla, MD
dbhatla@slu.edu

St. Louis University Medical Center
St. Louis, Missouri 63110
Contact:
Sagun Goyal, MD
sgoyal3@slu.edu

Washington University St. Louis
St. Louis, Missouri 63110
Contact:
Geoffrey Uy, MD
guy@wustl.edu

Washington University/St. Louis Children's Hospital
St. Louis, Missouri 63110
Contact:
Geoffrey Uy, MD
guy@wustl.edu

University of Nebraska Medical Center
Omaha, Nebraska 68198-2168
Contact:
Phyllis Warkenton, MD
pwarkent@unmc.edu

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Alfred Gillio, MD
agillio@humed.com

Robert Wood Johnson/Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
Contact:
Matthew Matasar, MD, MS
mm3511@cinj.rutgers.edu

Children's Hospital at Montefiore
Bronx, New York 10467
Contact:
Mahvish Rahim, MD
mrahim@montefiore.org

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Philip McCarthy, MD
philip.mccarthy@roswellpark.org

North Shore University Hospital
Lake Sucess, New York 11042
Contact:
Ruthee L Bayer, MD
rbayer@nshs.edu

Cohen Children's Medical Center of New York
New Hyde, New York 11040
Contact:
Jonathan Fish, MD
jfish1@nshs.edu

New York University Langone Medical Center
New York, New York 10016
Contact:
A. Samer Al-Homsi, MD
Samer.Al-Homsi@nyumc.org

New York Presbyterian Hospital at Cornell
New York, New York 10021
Contact:
Tsiporah Shore, MD
tbs2001@med.cornell.edu

Mount Sinai Medical Center
New York, New York 10029
Contact:
Alla Keyzner, MD
alla.keyzner@mssm.edu

Columbia University Medical Center - Morgan Stanley Children's Hospital
New York, New York 10032
Contact:
Monica Bhatia, MD
mb2476@columbia.edu

Memorial Sloan-Kettering Cancer Center
New York, New York 10065
Contact:
Ioannis Politikos, MBBS
politiki@mskcc.org

Westchester Medical Center
New York, New York 10595
Contact:
Mitchell Cairo, MD
914-594-3640
mitchell_cairo@nymc.edu

Strong Memorial Hospital/University of Rochester
Rochester, New York 14642-8704
Contact:
Omar Aljitawi, MD
omar_aljitawi@urmc.rochester.edu

Stony Brook University Hospital
Stony Brook, New York 11794
Contact:
Michael Schuster, MD
mschuster@notes.cc.sunysb.edu

Levine Children's Hospital
Charlotte, North Carolina 28203
Contact:
Jeffrey Huo, MD
Jeffrey.Huo@carolinashealthcare.org

Duke University Medical Center
Durham, North Carolina 27705
Contact:
Joanne Kurtzberg, MD
kurtz001@mc.duke.edu

Childrens Hospital Medical Center of Akron
Akron, Ohio 44308
Contact:
Megan Sampson, MD
msampson@akronchildrens.org

Cincinnati Children's Hospital
Cincinnati, Ohio 45229
Contact:
Stella Davies, MD
stella.davies@cchmc.org

University Hospitals Case Medical Center
Cleveland, Ohio 44106
Contact:
Hillard Lazarus, MD
hillard.lazarus@case.edu

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Craig Sauter, MD
sauterc@ccf.org

Nationwide Children's Hospital
Columbus, Ohio 43205
Contact:
Rolla Abu-Arja, MD
rolla.abu-arja@nationwidechildrens.org

The Arthur G. James Cancer Hospital/The Ohio State University Medical Center
Columbus, Ohio 43210
Contact:
Sumithira Vasu, MD
sumithira.vasu@osumc.edu

University of Oklahoma Health Science Center
Oklahoma City, Oklahoma 73103
Contact:
Adam Asch, MD
adam-asch@ouhsc.edu

Oregon Health & Science University/Doernbecher Children's Hospital
Portland, Oregon 97239
Contact:
Eneida Nemecek, MD
nemeceke@ohsu.edu

Penn State Milton S. Hershey Cancer Center
Hershey, Pennsylvania 17033
Contact:
Shin Mineishi, MD
smineishi@pennstatehealth.psu.edu

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Contact:
Nancy Bunin, MD
buninn@email.chop.edu

Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
Contact:
Paul Szabolcs, MD
Paul.szabolcs@chp.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
Contact:
Alison Sehgal, MD
sehgalar@upmc.edu

Western Penn Hospital
Pittsburg, Pennsylvania 15224
Contact:
John Lister, MD
Jlister@wpahs.org

University of Pennsylvania/Thomas Jefferson
Pittsburg, Pennsylvania 19104
Contact:
Elizabeth Hexner, MD
elizabeth.hexner@uphs.upenn.edu

Roger Williams Medical Center
Providence, Rhode Island 02908
Contact:
Todd Roberts, MD
todd.roberts@chartercare.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Michelle Hudspeth, MD
843-792-2957
hudspeth@musc.edu

Avera Transplant Institute
Sioux Falls, South Dakota 57105
Contact:
Waqas Jehangir, MD, FACP
waqas.jehangir@avera.org

Methodist Healthcare Blood and Marrow Transplant Center
Memphis, Tennessee 38104
Contact:
Fnu Kaweeta, MD
fnu.kaweeta@mlh.org

St. Jude Childrens Research Hospital
Memphis, Tennessee 38105
Contact:
Renee Madden, MD
renee.madden@stjude.org

Vanderbilt University
Nashville, Tennessee 37232
Contact:
Michael Byrne, MD
michael.byrne@vumc.org

Medical City Dallas
Dallas, Texas 75230
Contact:
Vikas Bhushan, MD
vikas.bhushan@usoncology.com

Children's Medical Center Dallas
Dallas, Texas 75235
Contact:
Victor Aquino, MD
Victor.aquino@utsouthwestern.edu

Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)
Fort Sam Houston, Texas 78234
Contact:
Bradley Beeler, MD
bradley.w.beeler.mil@health.mil

Cook Children's Hospital
Fort Worth, Texas 76104
Contact:
Gretchen Eames, MD
gretchen.eames@cookchildrens.org

M.D. Anderson Cancer Center
Houston, Texas 77030
Contact:
Elizabeth Shpall, MD
eshpall@mdanderson.org

Texas Children's Hospital - Baylor Medical Center
Houston, Texas 77030
Contact:
Robert Krance, MD
832-824-4661
rakrance@txch.org

The Children's Hospital of San Antonio
San Antonio, Texas 78207
Contact:
Martin Andreansky, MD, PhD
martin.andreansky@bcm.edu

Methodist Healthcare System of San Antonio/Texas Transplant Institute
San Antonio, Texas 78229
Contact:
Jose Cruz, MD
josecarlos.cruz@hcahealthcare.com

University of Utah
Salt Lake City, Utah 84132
Contact:
Ahmad Rayes, MD
ahmad.rayes@hsc.utah.edu

University of Virginia
Charlottesville, Virginia 22908
Contact:
Karen Ballen, MD
KB3TC@hscmail.mcc.virginia.edu

Virginia Commonwealth University
Richmond, Virginia 23227
Contact:
John McCarty, MD
804-828-4596
jmccarty@vcu.edu

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
Contact:
Ann Dahlberg, MD
adahlber@fredhutch.org

West Virginia University
Morgantown, West Virginia 26506-8110
Contact:
Lauren Veltri, MD
lveltri@hsc.wvu.edu

University of Wisconsin - Madison
Madison, Wisconsin 53792
Contact:
Kenneth DeSantes, MD
kbdesantes@pediatrics.wisc.edu

Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
David Margolis, MD
dmargoli@mcw.edu

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Hamadani Mehdi, MD
414-805-0643
mhamadani@mcw.edu

More Details

NCT ID
NCT01351545
Status
Recruiting
Sponsor
Center for International Blood and Marrow Transplant Research

Study Contact

Lisa Erickson, MPH
10-CBA@ndmp.org

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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