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NCT00901225 · ClinicalTrials.gov registry record · Phase 2
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
A Phase 2 study of Multiple Myeloma and Non-Hodgkin's Lymphoma, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT00901225 is a Phase 2 study of Multiple Myeloma and Non-Hodgkin's Lymphoma that has completed, run by Duke University. The registered enrollment target is 21 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00901225, a Phase 2 study of Multiple Myeloma and Non-Hodgkin's Lymphoma, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population. The study hypothesis for this study is that patients with a circulating CD34+ count \< 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve \> or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
Conditions Studied
Interventions
- DRUG G-CSF plus Plerixafor
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00901225
The ClinicalTrials.gov registry entry for NCT00901225 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which G-CSF plus Plerixafor is the first listed.
NCT00901225 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00901225 about?
NCT00901225 is a clinical study titled "Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant". Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G...
What is the current status of trial NCT00901225?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2009-05. Estimated completion is 2013-05.
What conditions does trial NCT00901225 study?
This clinical trial studies the following conditions: Multiple Myeloma, Non-Hodgkin's Lymphoma, Hodgkin's Disease.
What interventions are being tested in trial NCT00901225?
The interventions under investigation include: G-CSF plus Plerixafor (DRUG).
Who is sponsoring clinical trial NCT00901225?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00901225 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.