Clinical Trial Details

NCT ID: NCT02730299
Date Last Changed: September 24, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of NiCord® and Cord Blood Unit

Research Study Title

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

Purpose

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 or chronic myeloid leukemia, all with required disease features rendering them eligible for allogeneic transplantation.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
16 to 60 Years
Overall Status
Recruiting
Lead Sponsor
Gamida Cell ltd
Duration
25 Months
Facility Type
N/A
Compensation

Eligibility

All ages 16 Years to 60 Years

Inclusion Criteria:

  • Applicable disease criteria

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

  • Back-up stem cell source

  • Adequate Karnofsky 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

Site Locations (7)

Country State City Zip Facility and Contact
United States Illinois Maywood 60153 Loyola University, Cardinal Bernardin Cancer Center
Patrick Stiff, MD
708-327-3216
pstiff@lumc.edu

Patrick Stiff, MD
Principal Investigator
United States Minnesota Minneapolis 55455 University of Minnesota Masonic Cancer Center
John Wagner, MD
612-626-2961
wagne002@umn.edu

John Wagner, MD
Principal Investigator
United States North Carolina Durham 27710 Duke University Medical Center
Mitchell Horwitz, MD
919-668-1045
mitchell.horwitz@duke.edu

Mitchell Horwitz, MD
Principal Investigator
United States Ohio Cleveland 44195 Cleveland Clinic Children's
Rabi Hanna, MD
216-444-0663
Hannar2@ccf.org

Rabi Hanna, MD
Principal Investigator
Netherlands Utrecht 3503 AB University Medical Center Utrecht
Jaap Jan Boelens, MD
+31-88-7554003
J.J.Boelens@umcutrecht.nl

Jaap Jan Boelens, MD
Principal Investigator
Spain Barcelona 08035 University Hospital Vall d'Hebron
David Valcárcel, MD, PhD
+34-934 893 000 ext. 6417
dvalcarcel.vhebron@me.com

David Valcárcel, MD, PhD
Principal Investigator
Spain Valencia 46009 Hospital Universitario La Fe
Guillermo Sanz, MD
+34 (96) 386-2709
sanz_gui@gva.es

Guillermo Sanz, MD
Principal Investigator

Contact

Iddo Peleg, MSc. MBA
97226595630
E-mail:

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