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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01767714
First received: December 17, 2012
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Granulocyte-colony stimulating factor (G-CSF)
Drug: Plerixafor
Drug: Placebo
Phase 3

Study Type: 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
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis [ Time Frame: Day 5 - Day 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Total number of CD34+ cells collected [ Time Frame: Day 5 - Day 8 ] [ Designated as safety issue: No ]
  • Time from transplantation to neutrophil and platelet (PLT) engraftment [ Time Frame: up to 30 days post-transplantation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Time to reach Cmax (Tmax) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Area Under the Curve 0 to 10 hours post-dose (AUC0-10) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Area Under the Curve 0 to last observed concentration (AUClast) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Percentage of extrapolation of AUC (AUCext) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Half life (T1/2) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Volume of distribution (Vz/F) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Total body clearance (CL/F) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • Peripheral blood CD34+ cell counts (Pharmacodynamic analysis) [ Time Frame: Day 4 - Day 5 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: Granulocyte-colony stimulating factor (G-CSF)
10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
Other Name: GRAN®, Filgrastim
Drug: Placebo
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767714

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
China
Investigational Site Number 156005 Recruiting
Beijing, China, 100071
Investigational Site Number 156003 Recruiting
Beijing, China, 100730
Investigational Site Number 156002 Recruiting
Beijing, China, 100142
Investigational Site Number 156017 Recruiting
Beijing, China, 100034
Investigational Site Number 156001 Recruiting
Beijing, China, 100044
Investigational Site Number 156014 Recruiting
Changsha, China, 410008
Investigational Site Number 156020 Active, not recruiting
Chongqing, China, 400037
Investigational Site Number 156016 Active, not recruiting
Fuzhou, China, 350001
Investigational Site Number 156012 Recruiting
Guangzhou, China, 510515
Investigational Site Number 156021 Recruiting
Guangzhou, China, 510060
Investigational Site Number 156011 Recruiting
Hangzhou, China, 310003
Investigational Site Number 156018 Recruiting
Nanjing, China, 210029
Investigational Site Number 156009 Recruiting
Shanghai, China, 200025
Investigational Site Number 156019 Recruiting
Shanghai, China, 200433
Investigational Site Number 156010 Recruiting
Suzhou, China, 215006
Investigational Site Number 156008 Recruiting
Tianjin, China, 300020
Investigational Site Number 156013 Recruiting
Wuhan, China, 430022
Investigational Site Number 156015 Recruiting
Xi'An, China, 710038
Investigational Site Number 156022 Recruiting
Zhengzhou, China, 450008
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01767714     History of Changes
Other Study ID Numbers: EFC12482, MOZ14409, U1111-1131-0145
Study First Received: December 17, 2012
Last Updated: August 25, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014