Know Cancer

or
forgot password

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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis

Outcome Time Frame:

Days 5- Day8

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Food and Drug Administration

Study ID:

EFC12482

NCT ID:

NCT01767714

Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • hematopoietic stem cell transplantation
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location