CompletedPhase 3

Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

United States36 participantsStarted 2020-07-08

Plain-language summary

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must be at least 12 years of age * Applicable disease criteria * Patients must have one or two partially HLA-matched CBUs * Back-up stem cell source * Sufficient physiological reserves * Females of childbearing potential agree to use appropriate method of contraception * Signed written informed consent Exclusion Criteria: * Extensive bone marrow fibrosis * Donor specific anti-HLA antibodies * Pregnancy * Medically unsuitable for transplant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time From Transplant to Neutrophil Engraftment

Timeframe: by day 42 post-transplant inclusive

Cumulative Incidence of Neutrophil Engraftment

Timeframe: by day 42 post-transplant inclusive

Trial details

NCT IDNCT04260698

SponsorGamida Cell ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-08

Results submitted2026-02-23

View on ClinicalTrials.gov More Hematological Malignancies trials

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.