ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 3349 for:    adult stem cell transplants | Interventional Studies

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00396331
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : December 2, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Autologous Stem Cell Transplantation
Intervention: Drug: G-CSF plus plerixafor

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four participants were enrolled in the study but never received plerixafor treatment so are not included below. Reasons for not receiving plerixafor included disease progression (2), infection (1) and insurance issues (1).

Reporting Groups
  Description
G-CSF Plus Plerixafor Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.

Participant Flow:   Overall Study
    G-CSF Plus Plerixafor
STARTED   100 
Number of Participants Treated   100 
Number of Participants Transplanted   87 [1] 
COMPLETED   68 
NOT COMPLETED   32 
Failed to mobilize - no transplant                8 
Did not go on to transplant                5 
Lost to Follow-up                3 
Death                16 
[1] 7 participants had two transplants



  Baseline Characteristics

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
Non-Hodgkin's Lymphoma Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
Hodgkin's Disease Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
Multiple Myeloma Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
Other Cancers Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
Total Total of all reporting groups

Baseline Measures
   Non-Hodgkin's Lymphoma   Hodgkin's Disease   Multiple Myeloma   Other Cancers   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   21   10   3   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (10.0)   45.6  (15.5)   62.6  (11.3)   32.7  (28.9)   54.4  (13.6) 
Gender 
[Units: Participants]
         
Female   29   10   5   1   45 
Male   37   11   5   2   55 
Race/Ethnicity, Customized 
[Units: Participants]
         
Caucasian   60   17   9   3   89 
Black or African American   3   1   1   0   5 
Asian   2   1   0   0   3 
Hispanic/Latino   1   2   0   0   3 


  Outcome Measures

1.  Primary:   Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period   [ Time Frame: Day 1 to approximately day 38 ]

2.  Primary:   Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF   [ Time Frame: Day 5 to Day 11 (up to 7 apheresis) ]

3.  Primary:   Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF   [ Time Frame: Day 5 to Day 11 (up to 7 aphereses) ]

4.  Secondary:   Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment   [ Time Frame: approximately 2 months (1 month post transplant) ]

5.  Secondary:   Median Number of Days to Platelet (PLT) Engraftment   [ Time Frame: Approximately 2 months (1 month post transplant) ]

6.  Secondary:   Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation   [ Time Frame: Approximately 13 months (12 months post transplant ) ]

7.  Secondary:   Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration   [ Time Frame: Up to Day 7 ]

8.  Secondary:   Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF   [ Time Frame: Day 5 up to Month 6 (up to 7 aphereses in each course of treatment) ]

9.  Secondary:   Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF   [ Time Frame: Day 5 up to Month 6 (up to 7 aphereses in each course of treatment) ]

10.  Secondary:   Maximum Observed Plasma Concentration (Cmax) on Day 4   [ Time Frame: Day 4 (following first plerixafor administration) ]

11.  Secondary:   Maximum Observed Plasma Concentration (Cmax) on Day 7   [ Time Frame: Day 7 (following fourth plerixafor administration) ]

12.  Secondary:   Time to Maximum Plasma Concentration (Tmax) on Day 4   [ Time Frame: Day 4 (following first plerixafor administration) ]

13.  Secondary:   Time to Maximum Plasma Concentration (Tmax) on Day 7   [ Time Frame: Day 7 (following fourth plerixafor administration) ]

14.  Secondary:   Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4   [ Time Frame: Days 4 -5 (following first plerixafor administration) ]

15.  Secondary:   Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7   [ Time Frame: Days 7-8 (following fourth plerixafor administration) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Medical Monitor
Organization: Genzyme
e-mail: medinfo@genzyme.com



Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00396331     History of Changes
Other Study ID Numbers: AMD31002112
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: November 2, 2010
Results First Posted: December 2, 2010
Last Update Posted: March 13, 2014