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NCT00396201 · ClinicalTrials.gov registry record · Phase 2

AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

A Phase 2 study, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT00396201 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 22 participants.

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The verdict

NCT00396201, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5\*10\^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

Interventions

  • DRUG G-CSF Plus Plerixafor

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2004-11
Est. Completion 2008-01
Phase Phase 2

Sponsor

Genzyme, a Sanofi Company

196 total trials

What the Registry Record Tells You About NCT00396201

The ClinicalTrials.gov registry entry for NCT00396201 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which G-CSF Plus Plerixafor is the first listed.

NCT00396201 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00396201 about?

NCT00396201 is a clinical study titled "AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease". Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the ...

What is the current status of trial NCT00396201?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2004-11. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00396201?

The interventions under investigation include: G-CSF Plus Plerixafor (DRUG).

Who is sponsoring clinical trial NCT00396201?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.