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

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

  • 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

Eligibility

Eligible Ages
All ages
Eligible Sex
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 4049979, Alabama 4829764 35233
Contact:
Joseph Chewning, MD
jchewning@peds.uab.edu

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234
Contact:
September Mitchell, RN
september.mitchell@bannerhealth.com

Mayo Clinic Arizona (adults)
Phoenix 5308655, Arizona 5551752 85054
Contact:
James Slack, MD
slack.james@mayo.edu

University of Arizona Medical Center - Tucson
Tucson 5318313, Arizona 5551752 85224
Contact:
Emmanuel Katsanis, MD
katsanis@peds.arizona.edu

Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202
Contact:
Jason Farrar, MD
JEFarrar@uams.edu

City of Hope
Duarte 5344147, California 5332921 91010
Contact:
Monzr Al Malki, MD
malmalki@coh.org

Children's Hospital of Los Angeles
Glendale 5352423, California 5332921 91204
Contact:
Neena Kapoor, MD
nkapoor@chla.usc.edu

Scripps Green Hospital
La Jolla 5363943, California 5332921 92037
Contact:
Jeffrey W Andrey, MD
andrey.jeffrey@scrippshealth.org

University of California San Diego
La Jolla 5363943, California 5332921 92093
Contact:
Edward Ball, MD
858-822-6600
tball@ucsd.edu

Loma Linda University Cancer Center
Loma Linda 5367696, California 5332921 92350
Contact:
Hisham Abdel-Azim, MD
habdelazim@llu.edu

UCLA
Los Angeles 5368361, California 5332921 90095
Contact:
Gary Schiller, MD
310-206-5755
gschiller@mednet.ucla.edu

Children's Hospital and Research Center of Oakland
Oakland 5378538, California 5332921 94609
Contact:
Mark Walters, MD
mwalters@mail.cho.org

Children's Hospital of Orange County (CHOC)
Orange 5379513, California 5332921 92868
Contact:
Rishikesh Chavan, MD
rishikesh.chavan@choc.org

Sutter Medical Center
Sacramento 5389489, California 5332921 95816
Contact:
Michael Carroll, MD
carrolmp@sutterhealth.org

Rady Children's Hospital San Diego
San Diego 5391811, California 5332921 92123
Contact:
Eric Anderson, MD
eanderson@rchsd.org

Stanford University Medical Center
Stanford 5398563, California 5332921 94304
Contact:
Andrew Rezvani, MD
arezvani@stanford.edu

Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
Contact:
Michael Verneris, MD
MICHAEL.VERNERIS@CUANSCHUTZ.EDU

University of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
Contact:
Jonathan Gutman, MD
jonathan.gutman@ucdenver.edu

Presbyterian St. Luke's/Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218
Contact:
Alireza Eghtedar, MD
alireza.eghtedar@healthonecares.com

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510
Contact:
Aaron Flagg, MD
aron.flagg@yale.edu

Nemours - Alfred I. duPont Hospital for Children
Brandywine 4141596, Delaware 4142224 19803
Contact:
Emi Caywood, MD
ecaywood@nemours.org

Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
David Jacobsohn, MD
dajacobs@childrensnational.org

University of Florida Shands Medical Center
Gainesville 4156404, Florida 4155751 32610
Contact:
Jordan Milner, MD
352-273-9120
jordan.milner@ufl.edu

Nemours Children's Hospital - Mayo Jacksonville
Jacksonville 4160021, Florida 4155751 32207
Contact:
Michael Joyce, MD
mjoyce@nemours.org

Mayo Clinic - Jacksonville
Jacksonville 4160021, Florida 4155751 32224
Contact:
Vivek Roy, MD
roy.vivek@mayo.edu

Niklaus Children's Hospital
Miami 4164138, Florida 4155751 33155
Contact:
Jorge Galvez-Silva, MD
jorgericardo.galvezsilva@nicklaushealth.org

AdventHealth Orlando
Orlando 4167147, Florida 4155751 32804
Contact:
Rushang Patel, MD
rushang.patel.md@adventhealth.com

Florida Center for Pediatric Cellular Therapy
Orlando 4167147, Florida 4155751 32804
Contact:
Susan Kelly, MD
susan.kelly.md@flhosp.org

All Children's Hospital
St. Petersburg 4171563, Florida 4155751 33701
Contact:
Deepakbabu Chellapandian, MD
dchella2@jhmi.edu

Children's Healthcare of Atlanta
Atlanta 4180439, Georgia 4197000 30322
Contact:
Ann Haight, MD
Ann.haight@choa.org

Northside Hospital
Atlanta 4180439, Georgia 4197000 30342
Contact:
Scott Solomon, MD
ssolomon@bmtga.com

Medical College of Georgia
Augusta 4180531, Georgia 4197000 30912
Contact:
Claude Sportes, MD
csportes@gru.edu

Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Randal Wada, MD
randalw@hawaii.edu

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Contact:
Kehinde Adekola, MD
kehinde-adekola@northwestern.edu

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Contact:
Sunita Nathan, MD

University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60612
Contact:
Damiano Rondelli, MD
drond@uic.edu

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60614
Contact:
Sonali Chaudhury, MD
schaudhury@luriechildrens.org

University of Chicago
Chicago 4887398, Illinois 4896861 60637
Contact:
James LaBelle, MD, PhD
jlabelle@peds.bsd.uchicago.edu

Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153
Contact:
Patrick Stiff, MD
pstiff@lumc.edu

Indiana Blood & Marrow Transplantation
Beech Grove 4254304, Indiana 4921868 46107
Contact:
Luke Akard, MD
lakard@ibmtindy.com

Indiana University/Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Jodi Skiles, MD
jskiles@iu.edu

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Margarida Silverman, MD
margarida-silverman@uiowa.edu

University of Kansas
Westwood 4281639, Kansas 4273857 66205
Contact:
Joseph McGuirk, DO
jmcguirk@kumc.edu

University of Louisville Hospital - James Brown Cancer Center
Louisville 4299276, Kentucky 6254925 40202
Contact:
William Tse, MD
w0tse002@louisville.edu

Tulane Medical Center
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Hana Safa, MD
hsafah@tulane.edu

Children's Hospital of New Orleans/LSUHSC
New Orleans 4335045, Louisiana 4331987 70118
Contact:
Lolie Yu, MD
(504) 896-9740
lyu@lsuhsc.edu

Johns Hopkins
Baltimore 4347778, Maryland 4361885 21287
Contact:
Allen Chen, MD, PhD
allenchen@jhmi.edu

Nih/Niaid
Bethesda 4348599, Maryland 4361885 20892-1456
Contact:
Elizabeth Kang, MD
ekang@niaid.nih.gov

Nih/Nhlbi
Bethesda 4348599, Maryland 4361885 20892
Contact:
Richard Childs, MD
childsr@nih.gov

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Andreas Klein, MD
617-636-8884
aklein2@tuftsmedicalcenter.org

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Corey Cutler, MD
cscutler@partners.org

University of Massachusetts
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Jan Cerny, MD
Jan.Cerny@umassmemorial.org

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Jessica Yu
jjxyu@med.umich.edu

Children's Hospital of Michigan
Detroit 4990729, Michigan 5001836 48201
Contact:
Sureyya Savasan, MD
ssavasan@med.wayne.edu

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
Contact:
Nalini Janakiraman, MD
njanaki1@hfhs.org

Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Troy Quigg, MD
troy.quigg@spectrumhealth.org

Spectrum Health
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Aly Abdel-Mageed, MD
aly.mageed@helendevoschildrens.org

Univeristy of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Contact:
Carolyn Bigelow, MD
cbigelow@umc.edu

Cardinal Glennon Children's Medical Center
St Louis 4407066, Missouri 4398678 63104
Contact:
Deepika Bhatla, MD
dbhatla@slu.edu

St. Louis University Medical Center
St Louis 4407066, Missouri 4398678 63110
Contact:
Sagun Goyal, MD
sgoyal3@slu.edu

Washington University St. Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Geoffrey Uy, MD
guy@wustl.edu

Washington University/St. Louis Children's Hospital
St Louis 4407066, Missouri 4398678 63110
Contact:
Geoffrey Uy, MD
guy@wustl.edu

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198-2168
Contact:
Phyllis Warkenton, MD
pwarkent@unmc.edu

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Alfred Gillio, MD
agillio@humed.com

Robert Wood Johnson/Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Matthew Matasar, MD, MS
mm3511@cinj.rutgers.edu

Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263
Contact:
Philip McCarthy, MD
philip.mccarthy@roswellpark.org

North Shore University Hospital
Lake Sucess, New York 5128638 11042
Contact:
Ruthee L Bayer, MD
rbayer@nshs.edu

Cohen Children's Medical Center of New York
New Hyde, New York 5128638 11040
Contact:
Jonathan Fish, MD
jfish1@nshs.edu

New York University Langone Medical Center
New York 5128581, New York 5128638 10016
Contact:
A. Samer Al-Homsi, MD
Samer.Al-Homsi@nyumc.org

New York Presbyterian Hospital at Cornell
New York 5128581, New York 5128638 10021
Contact:
Tsiporah Shore, MD
tbs2001@med.cornell.edu

Mount Sinai Medical Center
New York 5128581, New York 5128638 10029
Contact:
Alla Keyzner, MD
alla.keyzner@mssm.edu

Columbia University Medical Center - Morgan Stanley Children's Hospital
New York 5128581, New York 5128638 10032
Contact:
Monica Bhatia, MD
mb2476@columbia.edu

Memorial Sloan-Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Ioannis Politikos, MBBS
politiki@mskcc.org

Westchester Medical Center
New York 5128581, New York 5128638 10595
Contact:
Mitchell Cairo, MD
914-594-3640
mitchell_cairo@nymc.edu

Strong Memorial Hospital/University of Rochester
Rochester 5134086, New York 5128638 14642-8704
Contact:
Omar Aljitawi, MD
omar_aljitawi@urmc.rochester.edu

Stony Brook University Hospital
Stony Brook 5139865, New York 5128638 11794
Contact:
Michael Schuster, MD
mschuster@notes.cc.sunysb.edu

Children's Hospital at Montefiore
The Bronx 5110266, New York 5128638 10467
Contact:
Mahvish Rahim, MD
mrahim@montefiore.org

Levine Children's Hospital
Charlotte 4460243, North Carolina 4482348 28203
Contact:
Jeffrey Huo, MD
Jeffrey.Huo@carolinashealthcare.org

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27705
Contact:
Joanne Kurtzberg, MD
kurtz001@mc.duke.edu

Childrens Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418 44308
Contact:
Megan Sampson, MD
msampson@akronchildrens.org

Cincinnati Children's Hospital
Cincinnati 4508722, Ohio 5165418 45229
Contact:
Stella Davies, MD
stella.davies@cchmc.org

University Hospitals Case Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Hillard Lazarus, MD
hillard.lazarus@case.edu

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Craig Sauter, MD
sauterc@ccf.org

Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205
Contact:
Rolla Abu-Arja, MD
rolla.abu-arja@nationwidechildrens.org

The Arthur G. James Cancer Hospital/The Ohio State University Medical Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Sumithira Vasu, MD
sumithira.vasu@osumc.edu

University of Oklahoma Health Science Center
Oklahoma City 4544349, Oklahoma 4544379 73103
Contact:
Adam Asch, MD
adam-asch@ouhsc.edu

Oregon Health & Science University/Doernbecher Children's Hospital
Portland 5746545, Oregon 5744337 97239
Contact:
Eneida Nemecek, MD
nemeceke@ohsu.edu

Penn State Milton S. Hershey Cancer Center
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Shin Mineishi, MD
smineishi@pennstatehealth.psu.edu

Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Nancy Bunin, MD
buninn@email.chop.edu

Children's Hospital of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15224
Contact:
Paul Szabolcs, MD
Paul.szabolcs@chp.edu

Western Penn Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15224
Contact:
John Lister, MD
Jlister@wpahs.org

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Alison Sehgal, MD
sehgalar@upmc.edu

University of Pennsylvania/Thomas Jefferson
Pittsburgh 5206379, Pennsylvania 6254927 19104
Contact:
Elizabeth Hexner, MD
elizabeth.hexner@uphs.upenn.edu

Roger Williams Medical Center
Providence 5224151, Rhode Island 5224323 02908
Contact:
Todd Roberts, MD
todd.roberts@chartercare.org

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Michelle Hudspeth, MD
843-792-2957
hudspeth@musc.edu

Avera Transplant Institute
Sioux Falls 5231851, South Dakota 5769223 57105
Contact:
Waqas Jehangir, MD, FACP
waqas.jehangir@avera.org

Methodist Healthcare Blood and Marrow Transplant Center
Memphis 4641239, Tennessee 4662168 38104
Contact:
Fnu Kaweeta, MD
fnu.kaweeta@mlh.org

St. Jude Childrens Research Hospital
Memphis 4641239, Tennessee 4662168 38105
Contact:
Renee Madden, MD
renee.madden@stjude.org

Vanderbilt University
Nashville 4644585, Tennessee 4662168 37232
Contact:
Michael Byrne, MD
michael.byrne@vumc.org

Medical City Dallas
Dallas 4684888, Texas 4736286 75230
Contact:
Vikas Bhushan, MD
vikas.bhushan@usoncology.com

Children's Medical Center Dallas
Dallas 4684888, Texas 4736286 75235
Contact:
Victor Aquino, MD
Victor.aquino@utsouthwestern.edu

Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)
Fort Sam Houston 7267736, Texas 4736286 78234
Contact:
Bradley Beeler, MD
bradley.w.beeler.mil@health.mil

Cook Children's Hospital
Fort Worth 4691930, Texas 4736286 76104
Contact:
Gretchen Eames, MD
gretchen.eames@cookchildrens.org

M.D. Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Elizabeth Shpall, MD
eshpall@mdanderson.org

Texas Children's Hospital - Baylor Medical Center
Houston 4699066, Texas 4736286 77030
Contact:
Robert Krance, MD
832-824-4661
rakrance@txch.org

The Children's Hospital of San Antonio
San Antonio 4726206, Texas 4736286 78207
Contact:
Martin Andreansky, MD, PhD
martin.andreansky@bcm.edu

Methodist Healthcare System of San Antonio/Texas Transplant Institute
San Antonio 4726206, Texas 4736286 78229
Contact:
Jose Cruz, MD
josecarlos.cruz@hcahealthcare.com

University of Utah
Salt Lake City 5780993, Utah 5549030 84132
Contact:
Ahmad Rayes, MD
ahmad.rayes@hsc.utah.edu

University of Virginia
Charlottesville 4752031, Virginia 6254928 22908
Contact:
Karen Ballen, MD
KB3TC@hscmail.mcc.virginia.edu

Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23227
Contact:
John McCarty, MD
804-828-4596
jmccarty@vcu.edu

Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109
Contact:
Ann Dahlberg, MD
adahlber@fredhutch.org

West Virginia University
Morgantown 4815352, West Virginia 4826850 26506-8110
Contact:
Lauren Veltri, MD
lveltri@hsc.wvu.edu

University of Wisconsin - Madison
Madison 5261457, Wisconsin 5279468 53792
Contact:
Kenneth DeSantes, MD
kbdesantes@pediatrics.wisc.edu

Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
David Margolis, MD
dmargoli@mcw.edu

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 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

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.

Vanderbilt University Medical Center