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Gamida Cell: GC 05.01.020 Ph3 NiCord vs Unmanipulated UCB for Hematological Malignancies - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether NiCord transplants are better than transplants with standard, unmanipulated cord blood units (CBU).

What is the Condition Being Studied?

Acute lymphoblastic leukemia (ALL); Acute myelogenous leukemia (AML); Chronic myelogenous leukemia (CML); Chronic myelomonocytic leukemia (CMMoL); Myelodysplastic Syndrome (MDS); Lymphoma

Who Can Participate in the Study?

Patients 12-65 years of age who:
- Have a diagnosis of hematological malignancy
- Are candidates for unrelated cord blood transplantation
- Qualify with HLA-matched UCB units with sufficient pre-cryopreserved total nucleated cell dose and CD34+ cell dose

Age Group
Adults, Children

What is Involved?

If you choose to join the study, you will:
- Go through the following phases: screening, randomization, conditioning, and transplantation/follow-up
- Be randomized (like the flip of a coin) to receive either NiCord® or unmanipulated cord blood transplantation
- Be given medications to support you during study drug administration
- Receive unmanipulated CBU(s) or NiCord CF or NiCord NF through the central catheter (injection at the vein)
- Have bone marrow biopsies and/or aspirate, as needed
- Have heart and lung function tests while on the study
- CT Scan (or PET-CT) of your abdomen and pelvis, as needed
- Have blood tests to evaluate overall health and genetic testing
- Be in the study for approximately 478 days from the signing of informed consent to the last visit one year following transplantation
- Have the option to participate in a long term follow-up optional sub-study

Study Details

Full Title
A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00072499
NCT:NCT02730299
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698