Trials / Completed
CompletedNCT01164475
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, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect ≥5 x 10^6 CD34+ Cells/kg in ≤4 Days and to Evaluate the Difference in Total Systemic Exposure in Patients With Non-Hodgkin's Lymphoma Weighing ≤70 kg
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years – 78 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Granulocyte-colony stimulating factor (G-CSF) | |
| DRUG | Fixed Dose Plerixafor | |
| DRUG | Weight-Based Plerixafor |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2010-07-16
- Last updated
- 2014-02-25
- Results posted
- 2014-01-31
Locations
7 sites across 4 countries: United States, Canada, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT01164475. Inclusion in this directory is not an endorsement.