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NCT02730299 · ClinicalTrials.gov registry record · Phase 3

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

A Phase 3 study, sponsored by Gamida Cell.

Completed
Registry status
Phase 3
Development phase
125
Enrollment target

NCT02730299: Completed Phase 3 study, sponsored by Gamida Cell.

NCT02730299 is a Phase 3 study that has completed, run by Gamida Cell. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02730299, a Phase 3 study, has completed, sponsored by Gamida Cell.

COMPLETED
Registry status
Phase 3
Development phase
125 participants
Enrollment target

Study 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.

Primary Outcome

The time to engraftment of neutrophils \>500/μl was defined as per Center for International Blood and Marrow Transplant Research (CIBMTR) standards, requiring donor chimerism for neutrophil engraftment.

Interventions

  • DRUG NiCord® (omidubicel)
  • OTHER Cord Blood Unit

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2016-12-16
Est. Completion 2025-02-07
Phase Phase 3
Gamida Cell

8 total trials

What the finished NCT02730299 record still lists

NCT02730299 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which NiCord® (omidubicel) is the first listed.

NCT02730299 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02730299 about?

NCT02730299 is a clinical study titled "Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and 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 syndr...

What is the current status of trial NCT02730299?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2016-12-16. Estimated completion is 2025-02-07.

What interventions are being tested in trial NCT02730299?

The interventions under investigation include: NiCord® (omidubicel) (DRUG), Cord Blood Unit (OTHER).

Who is sponsoring clinical trial NCT02730299?

This trial is sponsored by Gamida Cell, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02730299's enrollment target sits among peer trials

125 1605th of 2000 higher than 391 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02730299, the US trial registry maintained by the National Library of Medicine. NCT02730299 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.