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

NCT ID: NCT01767714

Last Updated: 2014-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

hematopoietic stem cell transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Granulocyte-colony stimulating factor (G-CSF)

Intervention Type: DRUG

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

Plerixafor

Intervention Type: DRUG

0.24 mg/kg/day subcutaneous injection

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.

Group Type: PLACEBO_COMPARATOR

Granulocyte-colony stimulating factor (G-CSF)

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

Granulocyte-colony stimulating factor (G-CSF)

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

Intervention Type: DRUG

Plerixafor

0.24 mg/kg/day subcutaneous injection

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

GRAN®, Filgrastim; Mozobil, AMD3100, GZ316455

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 156017

Beijing, , China

Investigational Site Number 156001

Beijing, , China

Investigational Site Number 156005

Beijing, , China

Investigational Site Number 156002

Beijing, , China

Investigational Site Number 156003

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, , China

Countries

China

Other Identifiers

MOZ14409

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1131-0145

Identifier Type: OTHER

Identifier Source: secondary_id

EFC12482

Identifier Type: -

Identifier Source: org_study_id