A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Inclusion Criteria:
- Has a biopsy-confirmed diagnosis of NHL
- Is 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
- Treatment with an autologous peripheral HSC transplant is planned and the patient is
eligible for autologous transplantation
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Has recovered from all acute toxic effects of prior chemotherapy or other cancer
treatment.
- Has an actual body weight <175% of their ideal body weight (IBW)
- The patient agrees to use a highly effective method of contraception from Day 1
through ≥3 months following plerixafor treatment.
Exclusion Criteria:
- Concurrent serious illness and pathological conditions
- Has undergone previous HSC collections or collection attempt
- Has had any autologous or allogeneic HSC transplant
- Has active central nervous system (CNS) involvement
- Bone marrow lymphoma cells involvement >20%, as assessed by bone marrow biopsy within
4 months before signing the ICF
- Has received radiation therapy to the pelvis
- Has a diagnosis of all leukemias including any type of CLL
- Active infection
- Pregnant or nursing
- Anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm
- Received any prior radio-immunotherapy
- Prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) within 6 weeks prior to first dose
of G-CSF
- Prior cancer therapy, other investigational therapy within 4 weeks prior to first
dose of G-CSF
- Prior granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim
within 3 weeks prior to the first dose of G-CSF
- Prior G-CSF within 2 weeks prior to the first dose of G-CSF
- Inadequate organ funtion evidenced by unacceptable laboratory result