For Healthcare Professionals

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Applicable disease criteria
  2. Patients must have one or two partially HLA-matched CBUs
  3. Back-up stem cell source
  4. Adequate Karnofsky/Lansky Performance score
  5. Sufficient physiological reserves
  6. Signed written informed consent

EXCLUSION CRITERIA

  1. HLA-matched donor able to donate
  2. Prior allogeneic HSCT
  3. Other active malignancy
  4. Active or uncontrolled infection
  5. Active/symptoms of central nervous system (CNS) disease
  6. Pregnancy or lactation
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 97226595630Email iconEmail Study Center

Study’s details


Contition

Acute Leukemia,Acute Lymphoblastic Leukemia (ALL),Acute Myelogenous Leukemia (AML),Acute Myeloid Leukemia (AML),Chronic Myelogenous Leukemia (CML),Chronic Myeloid Leukemia (CML),Hematological Malignancies,Lymphoma,Myelodysplastic Syndrome (MDS)

Age

12+

Phase

Phase 3

Participants needed

125

Est. Completion Date

Apr 2024

Treatment type

Interventional


Sponsor

Gamida Cell ltd

ClinicalTrials.gov identifier

NCT02730299

Study number

GC P# 05.01.020

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