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

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ClinicalTrials.gov Identifier: NCT00914849
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : August 24, 2016
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematologic Neoplasms
Interventions Drug: AMD3100
Procedure: Leukopheresis
Procedure: Stem cell transplant
Enrollment 68
Recruitment Details The study opened to participant enrollment on 08/12/2009 and closed to participants enrollment on 01/31/2011.
Pre-assignment Details  
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description
  • 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

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

Period Title: Overall Study
Started 34 34
Completed 33 33
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Not eligible             0             1
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient Total
Hide Arm/Group Description
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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 of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
One recipient was not transplanted because of donor withdrawal of consent to collect a second day after a failed first day apheresis attempt.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
50
(28 to 65)
54
(25 to 68)
52
(25 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
16
  47.1%
12
  36.4%
28
  41.8%
Male
18
  52.9%
21
  63.6%
39
  58.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 33 participants 67 participants
34 33 67
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Completion of enrollment of all donors (17 months)
Hide Outcome Measure Data
Hide Analysis Population Description
3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection.
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 29 0
Measure Type: Number
Unit of Measure: participants
10
2.Secondary Outcome
Title Number of Donors Who Experience Grade 3-4 Infusional Toxicity
Hide Description [Not Specified]
Time Frame Up to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 34 0
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Number of Recipients Who Have Neutrophil Engraftment
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 33
Measure Type: Number
Unit of Measure: participants
33
4.Secondary Outcome
Title Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)
Hide Description

-Blood samples for pharmacokinetics were drawn on the following schedule:

  • prior to IV infusion
  • 15 minutes after start of infusion
  • 30 minutes after start of infusion
  • 1 hour after start of infusion
  • 4 hours after start of infusion
  • 6 hours after start of infusion
  • 9 hours after start of infusion
  • 24 hours after start of infusion
Time Frame Day 1 and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 34 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
1391  (488)
5.Secondary Outcome
Title Pharmacokinetics of IV AMD3100 as Measured by Half Life
Hide Description

-Blood samples for pharmacokinetics were drawn on the following schedule:

  • prior to IV infusion
  • 15 minutes after start of infusion
  • 30 minutes after start of infusion
  • 1 hour after start of infusion
  • 4 hours after start of infusion
  • 6 hours after start of infusion
  • 9 hours after start of infusion
  • 24 hours after start of infusion
Time Frame Day 1 and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 34 0
Mean (Standard Deviation)
Unit of Measure: hours
5.42  (1.24)
6.Secondary Outcome
Title Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)
Hide Description [Not Specified]
Time Frame Day 1 and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 34 0
Mean (Standard Deviation)
Unit of Measure: hr.ng/mL
5049  (1233)
7.Secondary Outcome
Title Rate of Acute GVHD (Grade II-IV) in Recipients
Hide Description [Not Specified]
Time Frame Day 0-Day 100 (acute)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 33
Measure Type: Number
Unit of Measure: participants
4
8.Secondary Outcome
Title Rate of Acute GVHD (Grade III-IV) in Recipients
Hide Description [Not Specified]
Time Frame Day 0-Day 100 (acute)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 33
Measure Type: Number
Unit of Measure: participants
4
9.Secondary Outcome
Title Time to Neutrophil Engraftment for Recipients
Hide Description Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.
Time Frame Up through Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 33
Median (Full Range)
Unit of Measure: days
14
(11 to 24)
10.Secondary Outcome
Title Time to Platelet Engraftment for Recipients
Hide Description Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.
Time Frame Up to Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 33
Median (Full Range)
Unit of Measure: days
25
(15 to 219)
11.Secondary Outcome
Title Transplant Related Mortality Rate for Recipients
Hide Description Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 33
Measure Type: Number
Unit of Measure: participants
1
12.Secondary Outcome
Title Grade 3-4 Toxicity for Recipients
Hide Description Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 34
Measure Type: Number
Unit of Measure: participants
Grade 3 fatigue 3
Grade 3 thrombocytopenia 1
Grade 3 mucositis 5
Grade 3 GI fistula 1
Grade 3 increased transaminase 2
Grade 3 febrile neutropenia 32
Grade 3 bacteremia+ 4
Grade 3 respiratory distress 1
Grade 3 renal failure 6
13.Secondary Outcome
Title Rate of Chronic GVHD in Recipients
Hide Description [Not Specified]
Time Frame Day 101-1 year
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients are not evaluable because they were not alive for the outcome measure time frame.
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 0 25
Measure Type: Number
Unit of Measure: participants
7
14.Secondary Outcome
Title Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure
Hide Description [Not Specified]
Time Frame Up to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description:
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

Overall Number of Participants Analyzed 34 0
Measure Type: Number
Unit of Measure: participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description
  • Day 1

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

    • AMD3100 320 ug/kg IV
    • Leukopheresis

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

All-Cause Mortality
Arm 1 - Donor Arm 2 - Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Donor Arm 2 - Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 - Donor Arm 2 - Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   33/33 (100.00%)   33/33 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  1/33 (3.03%)  0/33 (0.00%) 
Cardiac disorders     
Chest pain  1  2/33 (6.06%)  0/33 (0.00%) 
Congestive heart failure  1  0/33 (0.00%)  1/33 (3.03%) 
Sinus bradycardia  1  8/33 (24.24%)  0/33 (0.00%) 
Tachycardia  1  0/33 (0.00%)  1/33 (3.03%) 
Gastrointestinal disorders     
Abdominal cramping  1  17/33 (51.52%)  0/33 (0.00%) 
Constipation  1  0/33 (0.00%)  8/33 (24.24%) 
Diarrhea  1  12/33 (36.36%)  16/33 (48.48%) 
Distension/abdominal bloating  1  10/33 (30.30%)  6/33 (18.18%) 
GI fistula  1  0/33 (0.00%)  1/33 (3.03%) 
Mucositis  1  0/33 (0.00%)  18/33 (54.55%) 
Nausea  1  7/33 (21.21%)  13/33 (39.39%) 
Vomiting  1  0/33 (0.00%)  12/33 (36.36%) 
General disorders     
Catheter site pain  1  0/33 (0.00%)  5/33 (15.15%) 
Cold sensation  1  3/33 (9.09%)  0/33 (0.00%) 
Fatigue  1  0/33 (0.00%)  13/33 (39.39%) 
Fever  1  0/33 (0.00%)  2/33 (6.06%) 
Generalized weakness  1  0/33 (0.00%)  30/33 (90.91%) 
Lower extremities edema  1  0/33 (0.00%)  13/33 (39.39%) 
Sweating (diaphoresis)  1  5/33 (15.15%)  0/33 (0.00%) 
Warm sensation  1  1/33 (3.03%)  0/33 (0.00%) 
Infections and infestations     
Bacteremia  1  0/33 (0.00%)  4/33 (12.12%) 
Catheter site infection  1  0/33 (0.00%)  3/33 (9.09%) 
Febrile neutropenia  1  0/33 (0.00%)  32/33 (96.97%) 
Parotiditis  1  0/33 (0.00%)  1/33 (3.03%) 
Upper respiratory infection  1  0/33 (0.00%)  3/33 (9.09%) 
Urinary tract infection  1  0/33 (0.00%)  1/33 (3.03%) 
Investigations     
Hyperbiluribinemia  1  0/33 (0.00%)  7/33 (21.21%) 
Increase transaminase  1  0/33 (0.00%)  8/33 (24.24%) 
Thrombocytopenia  1  4/33 (12.12%)  2/33 (6.06%) 
Weight loss  1  0/33 (0.00%)  3/33 (9.09%) 
Metabolism and nutrition disorders     
Anorexia  1  0/33 (0.00%)  3/33 (9.09%) 
Hyperglycemia  1  0/33 (0.00%)  4/33 (12.12%) 
Hyperkalemia  1  0/33 (0.00%)  14/33 (42.42%) 
Hypocalcemia  1  24/33 (72.73%)  0/33 (0.00%) 
Hypokalemia  1  0/33 (0.00%)  1/33 (3.03%) 
Hypomagnesemia  1  0/33 (0.00%)  8/33 (24.24%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/33 (0.00%)  3/33 (9.09%) 
Leg pain  1  0/33 (0.00%)  3/33 (9.09%) 
Muscle weakness  1  0/33 (0.00%)  1/33 (3.03%) 
Neck pain  1  0/33 (0.00%)  1/33 (3.03%) 
Nervous system disorders     
Headache  1  2/33 (6.06%)  7/33 (21.21%) 
Lightheadedness  1  5/33 (15.15%)  0/33 (0.00%) 
Sensory neuropathy  1  23/33 (69.70%)  0/33 (0.00%) 
Vasovagal episode  1  6/33 (18.18%)  0/33 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/33 (0.00%)  13/33 (39.39%) 
Hand tremor  1  0/33 (0.00%)  1/33 (3.03%) 
Insomnia  1  4/33 (12.12%)  1/33 (3.03%) 
Mental status change  1  0/33 (0.00%)  2/33 (6.06%) 
Renal and urinary disorders     
Hematuria  1  0/33 (0.00%)  1/33 (3.03%) 
Incontinence  1  0/33 (0.00%)  1/33 (3.03%) 
Renal failure  1  0/33 (0.00%)  6/33 (18.18%) 
Urinary frequency/urgency  1  0/33 (0.00%)  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress  1  0/33 (0.00%)  1/33 (3.03%) 
Cough  1  0/33 (0.00%)  2/33 (6.06%) 
Dyspnea  1  3/33 (9.09%)  9/33 (27.27%) 
Throat pain  1  0/33 (0.00%)  5/33 (15.15%) 
Skin and subcutaneous tissue disorders     
Purpura  1  0/33 (0.00%)  1/33 (3.03%) 
Rash  1  0/33 (0.00%)  1/33 (3.03%) 
Skin nodules  1  0/33 (0.00%)  1/33 (3.03%) 
Vascular disorders     
Hot flashes  1  0/33 (0.00%)  2/33 (6.06%) 
Hypertension  1  0/33 (0.00%)  2/33 (6.06%) 
Hypotension  1  7/33 (21.21%)  3/33 (9.09%) 
Thrombosis/embolism (DVT)  1  0/33 (0.00%)  1/33 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John DiPersio, M.D., Ph.D.
Organization: Washington University School of Medicine
Phone: 314-454-8304
EMail: 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
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
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00914849     History of Changes
Other Study ID Numbers: 09-0713 / 201103429
First Submitted: June 1, 2009
First Posted: June 5, 2009
Results First Submitted: July 14, 2016
Results First Posted: August 24, 2016
Last Update Posted: May 17, 2017