Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00914849
First received: June 1, 2009
Last updated: July 14, 2016
Last verified: July 2016
Results First Received: July 14, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hematologic Neoplasms
Interventions: Drug: AMD3100
Procedure: Leukopheresis
Procedure: Stem cell transplant

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 08/12/2009 and closed to participants enrollment on 01/31/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1 - Donor
  • Day 1

    • AMD3100 320 ug/kg intravenous (IV)
    • Leukopheresis
  • Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)

    • AMD3100 320 ug/kg IV
    • Leukopheresis
Arm 2 - Recipient

Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM

Day 0 = Stem Cell Transplant


Participant Flow:   Overall Study
    Arm 1 - Donor     Arm 2 - Recipient  
STARTED     34     34  
COMPLETED     33     33  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 0  
Not eligible                 0                 1  



  Baseline Characteristics
  Hide 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.
One recipient was not transplanted because of donor withdrawal of consent to collect a second day after a failed first day apheresis attempt.

Reporting Groups
  Description
Arm 1 - Donor
  • Day 1

    • AMD3100 320 ug/kg IV
    • Leukopheresis
  • Day 2 (if PBSC collected is not sufficient)

    • AMD3100 320 ug/kg IV
    • Leukopheresis
Arm 2 - Recipient

Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM

Day 0 = Stem Cell Transplant

Total Total of all reporting groups

Baseline Measures
    Arm 1 - Donor     Arm 2 - Recipient     Total  
Number of Participants  
[units: participants]
  34     33     67  
Age  
[units: years]
Median (Full Range)
  50  
  (28 to 65)  
  54  
  (25 to 68)  
  52  
  (25 to 68)  
Gender  
[units: participants]
     
Female     16     12     28  
Male     18     21     39  
Region of Enrollment  
[units: participants]
     
United States     34     33     67  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant   [ Time Frame: Completion of enrollment of all donors (17 months) ]

2.  Secondary:   Number of Donors Who Experience Grade 3-4 Infusional Toxicity   [ Time Frame: Up to Day 2 ]

3.  Secondary:   Number of Recipients Who Have Neutrophil Engraftment   [ Time Frame: Day 21 ]

4.  Secondary:   Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)   [ Time Frame: Day 1 and Day 2 ]

5.  Secondary:   Pharmacokinetics of IV AMD3100 as Measured by Half Life   [ Time Frame: Day 1 and Day 2 ]

6.  Secondary:   Rate of Acute GVHD (Grade II-IV) in Recipients   [ Time Frame: Day 0-Day 100 (acute) ]

7.  Secondary:   Rate of Acute GVHD (Grade III-IV) in Recipients   [ Time Frame: Day 0-Day 100 (acute) ]

8.  Secondary:   Time to Neutrophil Engraftment for Recipients   [ Time Frame: Up through Day 100 ]

9.  Secondary:   Time to Platelet Engraftment for Recipients   [ Time Frame: Up to Day 100 ]

10.  Secondary:   Transplant Related Mortality Rate for Recipients   [ Time Frame: Day 100 ]

11.  Secondary:   Grade 3-4 Toxicity for Recipients   [ Time Frame: 1 year ]

12.  Secondary:   Rate of Chronic GVHD in Recipients   [ Time Frame: Day 101-1 year ]

13.  Secondary:   Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure   [ Time Frame: Up to Day 2 ]

14.  Secondary:   Pharmacodynamics of IV AMD3100 on Stem Cell and T-cell Phenotyping and on Immune Reconstitution After Transplantation.   [ Time Frame: Day 1 and Day 2 ]
Results not yet reported.   Anticipated Reporting Date:   10/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John DiPersio, M.D., Ph.D.
Organization: Washington University School of Medicine
phone: 314-454-8304
e-mail: jdipersi@dom.wustl.edu


Publications:
Broxmeyer HE, Hangoc G, Cooper S, Bridger G. Interference of the SDF-1/CXCR4 axis in mice with AMD3100 induces rapid high level mobilization of hematopoietic progenitor cells, and AMD3100 acts synergistically with G-CSF and MIP-1 alpha to mobilize progenitors. Blood. 2001;96:3371a
Broxmeyer HE, Hangoc G, Cooper S, Li X, Bridger G, Clapp DW. AMD3100, an antagonist of CXCR4 and mobilizer of myeloid progenitor cells, is a potent mobilizer of competitive repopulating long term marrow self renewing stem cells in mice. Blood. 2002;98:2397a
Liles WC, Broxmeyer HE, Rodger E, Hubel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale D. Leucocytosis and mobilization of pluripotent hematopoietic progenitor cells in healthy volunteers induced by single dose administration of AMD-3100, a CXCR4 antagonist. Blood. 2001;96:3071a
Devine S, Adkins D, Khoury H, Vij R, Goodnough LT, Graubert T, Tomasson M, Blum W, DiPersio J, Brown R. Mobilization of donors with GM-CSF plus G-CSF or GM-CSF alone results in significantly different graft composition compared to G-CSF alone. Blood. 2002;100:825a


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00914849     History of Changes
Other Study ID Numbers: 09-0713 / 201103429
Study First Received: June 1, 2009
Results First Received: July 14, 2016
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration