Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00103610
First received: February 11, 2005
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: February 6, 2009  
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
Condition: Lymphoma, Non-Hodgkin
Interventions: Drug: Granulocyte colony-stimulating factor plus plerixafor
Drug: Granulocyte colony-stimulating factor plus placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplant were recruited from 31 centers in the U.S. and 1 in Canada. The first participant was randomized on 18 January 2005 and the last participant’s last study visit occurred on 20 December 2007. A total of 298 participants were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
G-CSF Plus Plerixafor Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
G-CSF Plus Placebo Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Participant Flow:   Overall Study
    G-CSF Plus Plerixafor     G-CSF Plus Placebo  
STARTED     150     148  
COMPLETED     112     68  
NOT COMPLETED     38     80  
Entered Rescue Procedure                 10                 52  
Death                 16                 12  
Elective Withdrawal                 4                 0  
Lost to Follow-up                 3                 1  
Adverse Event                 2                 2  
Other                 2                 7  
Failed mobilization                 1                 5  
Noncompliance                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
G-CSF Plus Plerixafor Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
G-CSF Plus Placebo Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Total Total of all reporting groups

Baseline Measures
    G-CSF Plus Plerixafor     G-CSF Plus Placebo     Total  
Number of Participants  
[units: participants]
  150     148     298  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 10.9     57.5  ± 10.3     56.3  ± 10.7  
Gender  
[units: participants]
     
Female     50     46     96  
Male     100     102     202  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     136     140     276  
African-American     6     1     7  
Asian     2     2     4  
Hispanic/Latino     5     4     9  
Other     1     1     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis   [ Time Frame: Days 5 to 8 ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: up to Day 38 ]

3.  Secondary:   Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis   [ Time Frame: up to Day 8 ]

4.  Secondary:   Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg   [ Time Frame: up to Day 8 ]

5.  Secondary:   Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment   [ Time Frame: Up to Month 13 ]

6.  Secondary:   Median Number of Days to Platelet (PLT) Engraftment   [ Time Frame: Up to Month 13 ]

7.  Secondary:   Graft Durability at 100 Days Post Transplantation   [ Time Frame: approximately Day 138 ]

8.  Secondary:   Graft Durability at 6 Months Post Transplantation   [ Time Frame: approximately Month 7 ]

9.  Secondary:   Graft Durability at 12 Months Post Transplantation   [ Time Frame: approximately Month 13 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Genzyme MedInfo
Organization: Genzyme Corporation
e-mail: medinfo@genzyme.com


Publications of Results:

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00103610     History of Changes
Obsolete Identifiers: NCT00248508
Other Study ID Numbers: AMD3100-3101
Study First Received: February 11, 2005
Results First Received: February 6, 2009
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada