125 Participants Needed

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
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MH

Mitchell Horwitz, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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
See 3 more

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.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Therapy

Participants undergo conditioning therapy to prepare for transplantation

1-2 weeks

Transplantation

Participants receive either NiCord® or unmanipulated cord blood unit transplantation

1 day
1 visit (in-person)

Post-transplant Monitoring

Participants are monitored for neutrophil and platelet engraftment and infections

100 days

Follow-up

Participants are monitored for safety and effectiveness after transplantation

4 weeks

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: NiCord® (omidubicel)Experimental Treatment1 Intervention
Group II: Unmanipulated CBU(s)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gamida Cell ltd

Lead Sponsor

Trials
9
Recruited
290+
Unbiased ResultsWe believe in providing patients with all the options.
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