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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Plerixafor; Drug: Placebo; Drug: Granulocyte-colony stimulating factor (G-CSF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767714

EFC12482

U1111-1131-0145 (Other Identifier)

MOZ14409 (Other Identifier)

Details and patient eligibility

About

The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

G-CSF + plerixafor

Experimental group

Description:

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.

Treatment:

Drug: Granulocyte-colony stimulating factor (G-CSF)

Drug: Plerixafor

G-CSF + Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Granulocyte-colony stimulating factor (G-CSF)