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NCT01158118 · ClinicalTrials.gov registry record · Phase 2
Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01158118: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01158118 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01158118, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will gather information about the combination the drugs plerixafor with sargramostim in donors of blood-forming cells (stem cells). These stem cells will be collected from the donor and transplanted into their sibling. The investigators believe that the two drugs together will provide enough stem cells for transplantation and may also reduce the risk of graft versus host disease.
Primary Outcome
The primary endpoint is to reduce the number of donors treated with GM-CSF who require a second collection to obtain a minimum CD34/Kg (2 x 106) necessary for allogeneic stem cell transplantation when compared to historic controls mobilized with GM-CSF or plerixafor alone. A reduction in failed first leukapheresis from 40% to less than 10% as seen with G-CSF alone would be considered clinically meaningful.
Interventions
- DRUG Plerixafor
- DRUG Sargramostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 2 |
What the finished NCT01158118 record still lists
NCT01158118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Plerixafor is the first listed.
NCT01158118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01158118 about?
NCT01158118 is a clinical study titled "Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors". This study will gather information about the combination the drugs plerixafor with sargramostim in donors of blood-forming cells (stem cells). These stem cells will be collected from the donor and transplanted into their sibling. The investigators believe that the two drugs together will provide eno...
What is the current status of trial NCT01158118?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-04-01. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01158118?
The interventions under investigation include: Plerixafor (DRUG), Sargramostim (DRUG).
Who is sponsoring clinical trial NCT01158118?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01158118's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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