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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767714
First Posted: January 14, 2013
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
December 17, 2012
January 14, 2013
December 9, 2014
April 2013
November 2014   (Final data collection date for primary outcome measure)
Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis [ Time Frame: Days 5- Day8 ]
Same as current
Complete list of historical versions of study NCT01767714 on ClinicalTrials.gov Archive Site
  • Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis [ Time Frame: Day 5 - Day 8 ]
  • Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg [ Time Frame: Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg ]
  • Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg [ Time Frame: Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg ]
  • Total number of CD34+ cells collected [ Time Frame: Day 5 - Day 8 ]
  • Time from transplantation to neutrophil and platelet (PLT) engraftment [ Time Frame: up to 30 days post-transplantation ]
  • Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed ]
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 4 - Day 5 ]
  • Time to reach Cmax (Tmax) [ Time Frame: Day 4 - Day 5 ]
  • Area Under the Curve 0 to 10 hours post-dose (AUC0-10) [ Time Frame: Day 4 - Day 5 ]
  • Area Under the Curve 0 to last observed concentration (AUClast) [ Time Frame: Day 4 - Day 5 ]
  • Area Under the Curve (AUC) [ Time Frame: Day 4 - Day 5 ]
  • Percentage of extrapolation of AUC (AUCext) [ Time Frame: Day 4 - Day 5 ]
  • Half life (T1/2) [ Time Frame: Day 4 - Day 5 ]
  • Volume of distribution (Vz/F) [ Time Frame: Day 4 - Day 5 ]
  • Total body clearance (CL/F) [ Time Frame: Day 4 - Day 5 ]
  • Peripheral blood CD34+ cell counts (Pharmacodynamic analysis) [ Time Frame: Day 4 - Day 5 ]
  • 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 [ Time Frame: Day 5 - Day 8 ]
  • Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis [ Time Frame: Day 5 - Day 8 ]
  • Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg [ Time Frame: Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg ]
  • Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg [ Time Frame: Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg ]
  • Total number of CD34+ cells collected [ Time Frame: Day 5 - Day 8 ]
  • Time from transplantation to neutrophil and platelet (PLT) engraftment [ Time Frame: up to 30 days post-transplantation ]
  • Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed ]
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 4 - Day 5 ]
  • Time to reach Cmax (Tmax) [ Time Frame: Day 4 - Day 5 ]
  • Area Under the Curve 0 to 10 hours post-dose (AUC0-10) [ Time Frame: Day 4 - Day 5 ]
  • Area Under the Curve 0 to last observed concentration (AUClast) [ Time Frame: Day 4 - Day 5 ]
  • Area Under the Curve (AUC) [ Time Frame: Day 4 - Day 5 ]
  • Percentage of extrapolation of AUC (AUCext) [ Time Frame: Day 4 - Day 5 ]
  • Half life (T1/2) [ Time Frame: Day 4 - Day 5 ]
  • Volume of distribution (Vz/F) [ Time Frame: Day 4 - Day 5 ]
  • Total body clearance (CL/F) [ Time Frame: Day 4 - Day 5 ]
  • Peripheral blood CD34+ cell counts (Pharmacodynamic analysis) [ Time Frame: Day 4 - Day 5 ]
Not Provided
Not Provided
 
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
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: Granulocyte-colony stimulating factor (G-CSF)
    10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
    Other Name: GRAN®, Filgrastim
  • Drug: Plerixafor
    0.24 mg/kg/day subcutaneous injection
    Other Name: Mozobil, AMD3100, GZ316455
  • Drug: Placebo
    0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
  • Experimental: G-CSF + plerixafor
    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.
    Interventions:
    • Drug: Granulocyte-colony stimulating factor (G-CSF)
    • Drug: Plerixafor
  • Placebo Comparator: 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 placebo in the evening up to a maximum of 4 doses.
    Interventions:
    • Drug: Granulocyte-colony stimulating factor (G-CSF)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01767714
EFC12482
MOZ14409 ( Other Identifier: Genzyme )
U1111-1131-0145 ( Other Identifier: UTN )
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP