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

December 8, 2014 updated by: Sanofi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Investigational Site Number 156003
      • Beijing, China, 100034
        • Investigational Site Number 156017
      • Beijing, China, 100044
        • Investigational Site Number 156001
      • Beijing, China, 100071
        • Investigational Site Number 156005
      • Beijing, China, 100142
        • Investigational Site Number 156002
      • Chongqing, China, 400037
        • Investigational Site Number 156020
      • Fuzhou, China, 350001
        • Investigational Site Number 156016
      • Guangzhou, China, 510060
        • Investigational Site Number 156021
      • Hangzhou, China, 310003
        • Investigational Site Number 156011
      • Nanjing, China, 210029
        • Investigational Site Number 156018
      • Shanghai, China, 200025
        • Investigational Site Number 156009
      • Suzhou, China, 215006
        • Investigational Site Number 156010
      • Tianjin, China, 300020
        • Investigational Site Number 156008
      • Wuhan, China, 430022
        • Investigational Site Number 156013
      • Xi'An, China, 710038
        • Investigational Site Number 156015
      • Zhengzhou, China, 450008
        • Investigational Site Number 156022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • GRAN®, Filgrastim
Drug: Plerixafor
0.24 mg/kg/day subcutaneous injection
Other Names:
  • 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 Names:
  • GRAN®, Filgrastim
Drug: Placebo
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Days 5- Day8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis
Time Frame: Day 5 - Day 8
Day 5 - Day 8
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
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
Time Frame: Up to achieve the target of collecting ≥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
Time Frame: Day 5 - Day 8
Day 5 - Day 8
Time from transplantation to neutrophil and platelet (PLT) engraftment
Time Frame: up to 30 days post-transplantation
up to 30 days post-transplantation
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
from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed
Maximum plasma concentration (Cmax)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Time to reach Cmax (Tmax)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Area Under the Curve 0 to 10 hours post-dose (AUC0-10)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Area Under the Curve 0 to last observed concentration (AUClast)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Area Under the Curve (AUC)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Percentage of extrapolation of AUC (AUCext)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Half life (T1/2)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Volume of distribution (Vz/F)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Total body clearance (CL/F)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)
Time Frame: Day 4 - Day 5
Day 4 - Day 5
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
Day 5 - Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFC12482
  • MOZ14409 (Other Identifier: Genzyme)
  • U1111-1131-0145 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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