Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor, following the same study schedule as during the Double-Blind Treatment Period.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
