Stem Cell Transplantation with NiCord® for Blood Cancers

Recruiting at 51 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Gamida Cell ltd

Disqualifiers: Other malignancy, Infection, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mitchell Horwitz, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for patients with certain blood cancers like leukemia or lymphoma who need a stem cell transplant and don't have a fully matched donor. They should be in good enough health to undergo the procedure, not pregnant, without active infections or other cancers, and have a back-up stem cell source.

Inclusion Criteria

I have a backup source for stem cells.

My condition meets the specific disease criteria for the trial.

Signed written informed consent

Exclusion Criteria

I have had a stem cell transplant from a donor.

Pregnancy or lactation

I have a donor who is a perfect match for me.

Treatment Details

Interventions

• Cord Blood Unit
• NiCord® (Omidubicel)

Trial Overview The study compares NiCord® (omidubicel), an advanced cord blood unit, with standard unmanipulated cord blood units for stem cell transplantation in patients with specific types of leukemia and lymphoma.

Participant Groups

Group I: NiCord® (omidubicel) Experimental Treatment 1 Intervention

NiCord® is a cryopreserved stem/progenitor cell based product comprised of: 1. ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (NiCord® cultured fraction (CF)) 2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (NiCord® Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells. Both fractions, i.e. NiCord® CF and NiCord® NF, will be kept frozen until they are thawed and infused on the day of transplantation.

Group II: Unmanipulated CBU(s) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Gamida Cell ltd

Lead Sponsor

Trials

9

Recruited

290+