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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767714
• Other study ID #: EFC12482
• Secondary ID: MOZ14409U1111-11
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2012
• Last updated: December 8, 2014
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Granulocyte-colony stimulating factor (G-CSF)
10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
• Plerixafor
0.24 mg/kg/day subcutaneous injection
• Placebo
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156002	Beijing
China	Investigational Site Number 156003	Beijing
China	Investigational Site Number 156005	Beijing
China	Investigational Site Number 156017	Beijing
China	Investigational Site Number 156020	Chongqing
China	Investigational Site Number 156016	Fuzhou
China	Investigational Site Number 156021	Guangzhou
China	Investigational Site Number 156011	Hangzhou
China	Investigational Site Number 156018	Nanjing
China	Investigational Site Number 156009	Shanghai
China	Investigational Site Number 156010	Suzhou
China	Investigational Site Number 156008	Tianjin
China	Investigational Site Number 156013	Wuhan
China	Investigational Site Number 156015	Xi'An
China	Investigational Site Number 156022	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who meet the target of =5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis		Days 5- Day8	No
Secondary	Number of patients who achieve =2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis		Day 5 - Day 8	No
Secondary	Number of days of apheresis to collect =2 × 10^6 CD34+ cells/kg		Up to achieve the target of collecting =2 × 10^6 CD34+ cells/kg	No
Secondary	Number of days of apheresis to collect =5 × 10^6 CD34+ cells/kg		Up to achieve the target of collecting =5 × 10^6 CD34+ cells/kg	No
Secondary	Total number of CD34+ cells collected		Day 5 - Day 8	No
Secondary	Time from transplantation to neutrophil and platelet (PLT) engraftment		up to 30 days post-transplantation	No
Secondary	Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)		from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed	Yes
Secondary	Maximum plasma concentration (Cmax)		Day 4 - Day 5	No
Secondary	Time to reach Cmax (Tmax)		Day 4 - Day 5	No
Secondary	Area Under the Curve 0 to 10 hours post-dose (AUC0-10)		Day 4 - Day 5	No
Secondary	Area Under the Curve 0 to last observed concentration (AUClast)		Day 4 - Day 5	No
Secondary	Area Under the Curve (AUC)		Day 4 - Day 5	No
Secondary	Percentage of extrapolation of AUC (AUCext)		Day 4 - Day 5	No
Secondary	Half life (T1/2)		Day 4 - Day 5	No
Secondary	Volume of distribution (Vz/F)		Day 4 - Day 5	No
Secondary	Total body clearance (CL/F)		Day 4 - Day 5	No
Secondary	Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)		Day 4 - Day 5	No
Secondary	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		Day 5 - Day 8	No