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 range8 Years – 65 Years

SexALL

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

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

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