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NCT01816230 · ClinicalTrials.gov registry record · Phase 1
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
A Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Gamida Cell.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 15
- Study locations
NCT01816230: Completed Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Gamida Cell.
NCT01816230 is a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that has completed, run by Gamida Cell. The registered enrollment target is 36 participants, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816230, a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), has completed, sponsored by Gamida Cell.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 15
- Study locations
Study Summary
A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies.
Primary Outcome
Assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation.
Conditions Studied
Interventions
- DRUG NiCord®
Study Locations (15)
Other
- Children Hospital Gaslini Scientific Institute - Genoa
- University of Turin - Turin
- University Medical Center Utrecht - Utrecht
- National University Cancer Institute - Singapore
- Singapore General Hospital - Singapore
- University Hospital Vall d´Hebron - Barcelona
- Hospital Universitario La Fe - Valencia
California
- Cedars-Sinai Medical Center - Los Angeles
Illinois
- Loyola University, Cardinal Bernardin Cancer Center - Maywood
Minnesota
- University of Minnesota - Minneapolis
New York
- Steven and Alexandra Cohen Children's Medical Center - New York
North Carolina
- Duke University Medical Center - Durham
Ohio
- Cleveland Clinic - Cleveland
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-04 |
| Est. Completion | 2018-06 |
| Phase | Phase 1 |
What the finished NCT01816230 record still lists
NCT01816230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 1 intervention - of which NiCord® is the first listed.
NCT01816230 lists 15 locations in 9 states (Other, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT01816230 about?
NCT01816230 is a clinical study titled "Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM". A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies.
What is the current status of trial NCT01816230?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-04. Estimated completion is 2018-06.
What conditions does trial NCT01816230 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Acute Lymphoblastic Leukemia (ALL), Hematological Malignancies.
What interventions are being tested in trial NCT01816230?
The interventions under investigation include: NiCord® (DRUG).
Who is sponsoring clinical trial NCT01816230?
This trial is sponsored by Gamida Cell, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01816230 being conducted?
This trial has 15 study locations across California, Illinois, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia (AML)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01816230's enrollment target sits among peer trials
36 22nd of 29 higher than 7 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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.
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