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NCT01818284 · ClinicalTrials.gov registry record · Phase 2
Plerixafor for Stem Cell Mobilization in Normal Donors
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01818284: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01818284 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01818284, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs to be performed. Researchers will study if using both drugs lowers the risk of the stem cell transplant recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's body. The safety and effectiveness of this drug combination will also be studied. Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from the bone marrow to the blood.
Primary Outcome
Primary safety endpoint is the development of any unexpected toxicity (any grade 2 or higher non-hematologic toxicity) in donors. The severity of the toxicity - adverse events (AEs) graded according to Common Terminology Criteria v4.0 (CTCAE).
Interventions
- DRUG Plerixafor
- DRUG Filgrastim
- PROCEDURE Apheresis Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT01818284 record still lists
NCT01818284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Plerixafor is the first listed.
NCT01818284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01818284 about?
NCT01818284 is a clinical study titled "Plerixafor for Stem Cell Mobilization in Normal Donors". The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produ...
What is the current status of trial NCT01818284?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-10. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01818284?
The interventions under investigation include: Plerixafor (DRUG), Filgrastim (DRUG), Apheresis Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT01818284?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01818284's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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