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
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring hematopoietic stem cell transplantation
Eligibility Criteria
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
Sites / Locations
- Investigational Site Number 156017
- Investigational Site Number 156001
- Investigational Site Number 156005
- Investigational Site Number 156002
- Investigational Site Number 156003
- Investigational Site Number 156020
- Investigational Site Number 156016
- Investigational Site Number 156021
- Investigational Site Number 156011
- Investigational Site Number 156018
- Investigational Site Number 156009
- Investigational Site Number 156010
- Investigational Site Number 156008
- Investigational Site Number 156013
- Investigational Site Number 156015
- Investigational Site Number 156022
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
G-CSF + plerixafor
G-CSF + Placebo
Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses.
Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses.