Trial Search Results

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard Umbilical Cord Blood in Patients With Leukemia, Lymphoma, and Myelodysplastic Syndrome (MDS)

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gamida Cell ltd

Stanford Investigator(s):

Intervention(s):

  • Drug: NiCord® (omidubicel)
  • Other: Cord Blood Unit

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

12 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
khanh Nguyen
6507212372
Not Recruiting