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

NCT01767714 | Completed Phase 3

• 3 other identifiers: EFC12482MOZ14409U1111-1131-0145
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 16

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

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

  Days 5- Day8

Secondary Outcomes (17)

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

  Day 5 - Day 8

• 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

• 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

• Total number of CD34+ cells collected

  Day 5 - Day 8

• Time from transplantation to neutrophil and platelet (PLT) engraftment

  up to 30 days post-transplantation

Study Arms (2)

G-CSF + plerixafor

EXPERIMENTAL

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.

Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Plerixafor

G-CSF + Placebo

PLACEBO COMPARATOR

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.

Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Placebo

Interventions

Granulocyte-colony stimulating factor (G-CSF) DRUG

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

Also known as: GRAN®, Filgrastim

G-CSF + Placebo; G-CSF + plerixafor

Plerixafor DRUG

0.24 mg/kg/day subcutaneous injection

Also known as: Mozobil, AMD3100, GZ316455

G-CSF + plerixafor

Placebo DRUG

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

G-CSF + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (16)

Investigational Site Number 156017

Beijing, 100034, China

Location

Investigational Site Number 156001

Beijing, 100044, China

Location

Investigational Site Number 156005

Beijing, 100071, China

Location

Investigational Site Number 156002

Beijing, 100142, China

Location

Investigational Site Number 156003

Beijing, 100730, China

Location

Investigational Site Number 156020

Chongqing, 400037, China

Location

Investigational Site Number 156016

Fuzhou, 350001, China

Location

Investigational Site Number 156021

Guangzhou, 510060, China

Location

Investigational Site Number 156011

Hangzhou, 310003, China

Location

Investigational Site Number 156018

Nanjing, 210029, China

Location

Investigational Site Number 156009

Shanghai, 200025, China

Location

Investigational Site Number 156010

Suzhou, 215006, China

Location

Investigational Site Number 156008

Tianjin, 300020, China

Location

Investigational Site Number 156013

Wuhan, 430022, China

Location

Investigational Site Number 156015

Xi'an, 710038, China

Location

Investigational Site Number 156022

Zhengzhou, 450008, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Granulocyte Colony-Stimulating Factor; Granisetron; Filgrastim; plerixafor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: January 14, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

CN (16)