CompletedPhase 1/2

Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies

United States12 participantsStarted 2010-11

Plain-language summary

Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies

Who can participate

Age range

8 Years – 65 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: * Applicable disease and eligible for myeloablative SCT * Patients must have two partially HLA-matched CBUs * Back-up stem cell source * Adequate Karnofsky Performance score or Lansky Play-Performance scale * Sufficient physiological reserves * Signed written informed consent Exclusion Criteria: * HLA-matched related donor able to donate * Prior allogeneic HSCT * Lymphoma patients with progressive disease * Other active malignancy * Human immunodeficiency virus (HIV) infection * Active or uncontrolled infection * Active/symptoms of central nervous system (CNS) disease * Pregnancy or lactation

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

Acute Toxicity Associated With the Infusion of NiCord

Timeframe: 180 days post-transplant

Proportion of Patients With Neutrophil Engraftment

Timeframe: 42 days

Trial details

NCT IDNCT01221857

SponsorGamida Cell ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

Results submitted2017-05-24

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia (ALL) trials

Who can participate

Age range

8 Years – 65 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.