Clinical trial NCT01767714: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Keywords: hematopoietic stem cell transplantation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis
timeFrame: Days 5- Day8
Secondary outcomes:
measure: Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis
timeFrame: Day 5 - Day 8
measure: Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg
timeFrame: Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg
measure: Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg
timeFrame: Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg
measure: Total number of CD34+ cells collected
timeFrame: Day 5 - Day 8
measure: Time from transplantation to neutrophil and platelet (PLT) engraftment
timeFrame: up to 30 days post-transplantation
measure: Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 4 - Day 5
measure: Time to reach Cmax (Tmax)
timeFrame: Day 4 - Day 5
measure: Area Under the Curve 0 to 10 hours post-dose (AUC0-10)
timeFrame: Day 4 - Day 5
measure: Area Under the Curve 0 to last observed concentration (AUClast)
timeFrame: Day 4 - Day 5
measure: Area Under the Curve (AUC)
timeFrame: Day 4 - Day 5
measure: Percentage of extrapolation of AUC (AUCext)
timeFrame: Day 4 - Day 5
measure: Half life (T1/2)
timeFrame: Day 4 - Day 5
measure: Volume of distribution (Vz/F)
timeFrame: Day 4 - Day 5
measure: Total body clearance (CL/F)
timeFrame: Day 4 - Day 5
measure: Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)
timeFrame: Day 4 - Day 5
measure: The fold-increase in the number of circulating CD34+ following the first dose of plerixafor or placebo, with the first apheresis day (Day 5) value serving as the primary estimate
timeFrame: Day 5 - Day 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156017
city: Beijing
country: China
facility: Investigational Site Number 156001
city: Beijing
country: China
facility: Investigational Site Number 156005
city: Beijing
country: China
facility: Investigational Site Number 156002
city: Beijing
country: China
facility: Investigational Site Number 156003
city: Chongqing
country: China
facility: Investigational Site Number 156020
city: Fuzhou
country: China
facility: Investigational Site Number 156016
city: Guangzhou
country: China
facility: Investigational Site Number 156021
city: Hangzhou
country: China
facility: Investigational Site Number 156011
city: Nanjing
country: China
facility: Investigational Site Number 156018
city: Shanghai
country: China
facility: Investigational Site Number 156009
city: Suzhou
country: China
facility: Investigational Site Number 156010
city: Tianjin
country: China
facility: Investigational Site Number 156008
city: Wuhan
country: China
facility: Investigational Site Number 156013
city: Xi'An
country: China
facility: Investigational Site Number 156015
city: Zhengzhou
country: China
facility: Investigational Site Number 156022
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: