Status:
COMPLETED
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief 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 mob...
Detailed Description
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00103610
Start Date
January 1 2005
End Date
December 1 2007
Last Update
March 13 2014
Active Locations (32)
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1
City of Hope Samaritan Bone Marrow Transplant Program
Phoenix, Arizona, United States, 85006
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
4
Yale University School of Medicine
New Haven, Connecticut, United States, 06520