Overview

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genzyme, a Sanofi Company
Treatments:
JM 3100
Lenograstim
Plerixafor
Sargramostim
Criteria
Inclusion Criteria (Abbreviated List):

- Non-Hodgkin's lymphoma in first or second complete or partial remission

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- White Blood Cell count (WBC) > 2.5*10^9/L

- Platelet (PLT) > 100*10^9/L

Exclusion Criteria (Abbreviated List):

- Failed previous stem cell collection

- Prior autologous or allogeneic transplant

- Brain metastases or bone marrow involvement > 20%

- Radiation to pelvis

- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or
other conduction abnormality