Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Completed · Phase 3

Conditions studied: Hematological Malignancies

In brief

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Key facts

Study ID

NCT04260698

Run by

Gamida Cell ltd

People needed

36

Starts

2020-07-08

Expected to finish

2025-05-08

Last updated by the study team

2026-06-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be at least 12 years of age
• Applicable disease criteria
• Patients must have one or two partially HLA-matched CBUs
• Back-up stem cell source
• Sufficient physiological reserves
• Females of childbearing potential agree to use appropriate method of contraception
• Signed written informed consent

You may not qualify if…

• Extensive bone marrow fibrosis
• Donor specific anti-HLA antibodies
• Pregnancy
• Medically unsuitable for transplant

Where it is running

• UCLA — Los Angeles, California, United States
• Stanford University Cancer Institute — Palo Alto, California, United States
• Loyola University, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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