Transplantation of Ex Vivo Expanded, UCB-derived, Stem & Progenitor Cells vs. Unmanipulated UCB for HM Patients



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:12 - 65
Updated:3/30/2019
Start Date:November 2016
End Date:December 2020
Contact:Kelly Myers
Email:clinicaltrials@gamida-cell.com
Phone:+972-2-6595631

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A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies

This study is an open-label, controlled, multicenter, international, Phase III, randomized
study of transplantation of NiCord® versus transplantation of one or two unmanipulated,
unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid
leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required
disease features rendering them eligible for allogeneic transplantation.

Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient
number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone
marrow and regenerating a full array of hematopoietic cell lineages with early and late
repopulating ability in a timely fashion.

A major drawback of Umbilical Cord Blood (UCB) is the low stem cell dose available for
transplantation, compared to mobilized peripheral blood (PB) or bone marrow. This low stem
cell dose can compromise the chances of engraftment and contributes to delayed kinetics of
neutrophil and platelet recovery, as well as other transplant outcomes.

The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of
cells that have rapid and robust in vivo neutrophil and platelet producing potential to
enable successful transplantation.

NiCord® is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells
from one entire unit of UCB. NiCord® utilizes the small molecule nicotinamide (NAM), as an
epigenetic approach to inhibit differentiation and to increase the migration, bone marrow
(BM) homing and engraftment efficiency of Hematopoietic Progenitor Cells (HPC) expanded in ex
vivo cultures. The chief aim of the study is to compare the safety and efficacy of NiCord®
single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit
transplantation in patients with hematological malignancies following conditioning therapy.

Inclusion Criteria:

- Applicable disease criteria

- Patients must have one or two partially HLA-matched CBUs

- Back-up stem cell source

- Adequate Karnofsky/Lansky Performance score

- Sufficient physiological reserves

- Signed written informed consent

Exclusion Criteria:

- HLA-matched donor able to donate

- Prior allogeneic HSCT

- Other active malignancy

- Active or uncontrolled infection

- Active/symptoms of central nervous system (CNS) disease

- Pregnancy or lactation
We found this trial at
19
sites
Palo Alto, California 94305
Phone: 650-498-6000
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Leonid Volodin, MD
Phone: 434-924-9333
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Richard Maziarz, MD
Phone: 503-494-4606
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Baltimore, Maryland 21201
Phone: 410-328-7904
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Corey Cutler, MD
Phone: 617-851-2852
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Corey Cutler, MD
Phone: 617-851-2852
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Cleveland, Ohio
Principal Investigator: Rabi Hanna, MD
Phone: 216-444-0663
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Cleveland, OH
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Victor Aquino, MD
Phone: 214-456-2978
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Denver, Colorado 80045
Principal Investigator: Amy Keating, MD
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Detroit, Michigan 48202
Phone: 888-734-5322
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Mitchell Horwitz, MD
Phone: 919-668-1045
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Germantown, Tennessee 38138
Principal Investigator: Yasser Khaled, MD
Phone: 901-683-0055
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Haifa,
Phone: +972-4-777-3248
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Los Angeles, California 91010
Principal Investigator: Nicole Karras, MD
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Gary Schiller, MD
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Maywood, Illinois 60153
Principal Investigator: Patrick Stiff, MD
Phone: 708-327-3216
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Minneapolis, Minnesota 55455
Principal Investigator: Claudio Brunstein, MD
Phone: 612-625-3918
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New Brunswick, New Jersey 08903
Principal Investigator: Dennis Cooper, MD
Phone: 732-235-2465
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Westwood, Kansas 66205
Principal Investigator: Joseph McGuirk, MD
Phone: 913-945-6591
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