A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (240 µg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect =5 x 106 CD34+ Cells/kg in =4 Days a
Inclusion Criteria:
- Patients diagnosed with NHL who are eligible to receive treatment with autologous
peripheral stem cell transplant for the first time
- Biopsy-confirmed diagnosis of NHL
- Weight ≤ 70kg
- In first or second complete remission or partial remission, defined for the purpose
of this study as complete or partial response following first or second-line therapy
only
- At least 4 weeks since last cycle of chemotherapy and/or other cancer therapy
including rituximab
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy
- Negative for human immunodeficiency virus (HIV), active hepatitis B, and active
hepatitis C from assessments performed within 3 months before signing informed
consent
- Signed informed consent (ICF)
- White blood cell (WBC) count >2.5 × 10^9/L
- Absolute neutrophil count (ANC) >1.5 × 10^9/L
- Platelet (PLT) count >100 × 10^9/L
- Creatinine clearance ≥80 mL/min (estimated by Cockcroft-Gault formula or 24 hour
urine collection)
- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT), serum
glutamic pyruvic transaminase/alanine aminotransferase (SGPT), and total bilirubin
<2.5 × upper limit of normal
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
Exclusion Criteria:
- A co-morbid condition which, in the view of the Investigator(s), renders the patient
at high risk from treatment complications
- Failed previous hematopoietic stem cell(HSC) collections or collection attempts
- Prior autologous or allogeneic transplant
- Less than 6 weeks off 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) prior to first
dose of G CSF
- Active central nervous system involvement, active brain metastases, or any history of
carcinomatous meningitis (active or inactive)
- Bone marrow involvement >20%, as assessed by bone marrow biopsy within 4 months of
the first Screening assessment, unless a bone marrow biopsy was performed immediately
prior to the last chemotherapy and was negative and the patient responded to last
chemotherapy achieving a complete or partial remission
- Received radiation therapy to the pelvis
- Received granulocyte/macrophage-colony stimulating factor (GM CSF) or pegfilgrastim
within 3 weeks prior to the first dose of granulocyte colony stimulating factor (G
CSF) for mobilization
- Received G CSF within 14 days prior to the first dose of G CSF for mobilization.
- Received prior radio-immunotherapy with ibritumomab tiuxetan or tositumomab iodine
- Active infection, including unexplained fever (>38.1 °C / 100.4 °F), or antibiotic,
antiviral, or antifungal therapy within 7 days prior to the first dose of G-CSF
- Positive pregnancy test (female patients)
- Lactating (female patients)
- Abnormal electrocardiogram (ECG) with clinically significant rhythm disturbance
(ventricular arrhythmias) or other conduction abnormality in the last year that, in
the opinion of the Investigator(s), warrants exclusion of the patient from the trial
- Previously received experimental therapy within 4 weeks of enrolling or who are
currently enrolled in another experimental protocol during the G CSF and plerixafor
treatment period