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NCT Number: 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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 156001, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granulocyte-colony stimulating factor (G-CSF)

Drug

10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection

Other names: GRAN®, Filgrastim

plerixafor

Drug

0.24 mg/kg/day subcutaneous injection

Other names: Mozobil, AMD3100, GZ316455

Placebo

Drug

0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis

    Time frame: Day 5 - Day 8

  2. 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

  3. 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

  4. Total number of CD34+ cells collected

    Time frame: Day 5 - Day 8

  5. Time from transplantation to neutrophil and platelet (PLT) engraftment

    Time frame: up to 30 days post-transplantation

  6. 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

  7. Maximum plasma concentration (Cmax)

    Time frame: Day 4 - Day 5

  8. Time to reach Cmax (Tmax)

    Time frame: Day 4 - Day 5

  9. Area Under the Curve 0 to 10 hours post-dose (AUC0-10)

    Time frame: Day 4 - Day 5

  10. Area Under the Curve 0 to last observed concentration (AUClast)

    Time frame: Day 4 - Day 5

  11. Area Under the Curve (AUC)

    Time frame: Day 4 - Day 5

  12. Percentage of extrapolation of AUC (AUCext)

    Time frame: Day 4 - Day 5

  13. Half life (T1/2)

    Time frame: Day 4 - Day 5

  14. Volume of distribution (Vz/F)

    Time frame: Day 4 - Day 5

  15. Total body clearance (CL/F)

    Time frame: Day 4 - Day 5

  16. Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)

    Time frame: Day 4 - Day 5

  17. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2013
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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