Phase 3
Completed N=298
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT00103610 ↗
Enrolled (actual)
298
Serious AEs
6.1%
Results posted
Sep 2010
Primary outcomePrimary: Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis — 0.593; 0.196; 0.407; 0.804 proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis |
0.593; 0.196; 0.407; 0.804 | — |
| SECONDARY Number of Participants With Adverse Events |
146; 138; 98; 60; 3; 3 | — |
| SECONDARY Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis |
0.867; 0.473; 0.133; 0.527 | — |
| SECONDARY Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg |
3.0; NA | — |
| SECONDARY Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment |
10.0; 10.0 | — |
| SECONDARY Median Number of Days to Platelet (PLT) Engraftment |
20.0; 20.0 | — |
| SECONDARY Graft Durability at 100 Days Post Transplantation |
0.948; 0.951; 0.052; 0.049 | — |
| SECONDARY Graft Durability at 6 Months Post Transplantation |
0.976; 0.987; 0.024; 0.013 | — |
| SECONDARY Graft Durability at 12 Months Post Transplantation |
0.982; 1.0; 0.018; 0.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00103610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.