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NCT01164475 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT01164475: Completed Phase 4 study, sponsored by Genzyme, a Sanofi Company.
NCT01164475 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164475, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
Primary Outcome
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of \>=5\*10\^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Interventions
- DRUG Granulocyte-colony stimulating factor (G-CSF)
- DRUG Fixed Dose Plerixafor
- DRUG Weight-Based Plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT01164475 record still lists
NCT01164475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Granulocyte-colony stimulating factor (G-CSF) is the first listed.
NCT01164475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01164475 about?
NCT01164475 is a clinical study titled "Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms". The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
What is the current status of trial NCT01164475?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2010-10. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01164475?
The interventions under investigation include: Granulocyte-colony stimulating factor (G-CSF) (DRUG), Fixed Dose Plerixafor (DRUG), Weight-Based Plerixafor (DRUG).
Who is sponsoring clinical trial NCT01164475?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01164475's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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