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

• Status: Active, not recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gamida Cell ltd

Criteria

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