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

Not Recruiting

Trial ID: NCT04260698

Age - 12 Years-N/A Condition - Blood and Marrow Transplant (BMT), Leukemia, Myelodysplastic Syndromes (MDS), Acute Lymphoid leukemia (ALL), Chronic Myelogenous Leukemia (CML), Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL) Gender - All Accepting Healthy Volunteers - No

Purpose

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

Official Title

An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Stanford Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - Extensive bone marrow fibrosis

   - Donor specific anti-HLA antibodies

   - Pregnancy

   - Medically unsuitable for transplant

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Intervention(s):

biological: omidubicel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Khanh Nguyen
650-721-2372

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