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NCT04260698 · ClinicalTrials.gov registry record · Phase 3
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
A Phase 3 study of Hematological Malignancies, sponsored by Gamida Cell.
- Completed
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT04260698: Completed Phase 3 study of Hematological Malignancies, sponsored by Gamida Cell.
NCT04260698 is a Phase 3 study of Hematological Malignancies that has completed, run by Gamida Cell. The registered enrollment target is 36 participants, below the 774-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04260698, a Phase 3 study of Hematological Malignancies, has completed, sponsored by Gamida Cell.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Primary Outcome
Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10\^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive. The first day of the three measurements was designated the day of neutrophil engraftment.
Conditions Studied
Interventions
- BIOLOGICAL omidubicel
Study Locations (6)
California
- UCLA - Los Angeles
- Stanford University Cancer Institute - Palo Alto
Illinois
- Loyola University, Cardinal Bernardin Cancer Center - Maywood
Minnesota
- University of Minnesota Masonic Cancer Center - Minneapolis
North Carolina
- Duke University Medical Center - Durham
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 3 |
What the finished NCT04260698 record still lists
NCT04260698 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 774-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Hematological Malignancies appearing as the primary indexed condition, and to 1 intervention - of which omidubicel is the first listed.
NCT04260698 lists 6 locations in 5 states (California, Illinois, Minnesota).
Frequently Asked Questions
What is clinical trial NCT04260698 about?
NCT04260698 is a clinical study titled "Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies". Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
What is the current status of trial NCT04260698?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2020-07-08. Estimated completion is 2025-05-08.
What conditions does trial NCT04260698 study?
This clinical trial studies the following conditions: Hematological Malignancies.
What interventions are being tested in trial NCT04260698?
The interventions under investigation include: omidubicel (BIOLOGICAL).
Who is sponsoring clinical trial NCT04260698?
This trial is sponsored by Gamida Cell, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04260698 being conducted?
This trial has 6 study locations across California, Illinois, Minnesota, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04260698's enrollment target sits among peer trials
36 13th of 16 higher than 2 of 16 other Hematological Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematological Malignancies 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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