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Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkin's Disease

Phase 2
18 Years
70 Years
Not Enrolling
Hodgkin's Disease

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Trial Information

Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkin's Disease

Participants with HD who have been treated with cyto-reductive chemotherapy, who are to
undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria
are eligible to enter this study. The only changes to the standard of care is the addition
of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis and the
collection of blood samples for pharmacokinetic (PK) analysis and pharmacodynamics (PD)
analysis by CD34+ fluorescence-activated cell sorting (FACS) analysis. Blood samples for PK
and CD34+ FACS analyses will be obtained prior to and after the first dose of plerixafor.
Participants will undergo mobilization with G-CSF (10 µg/kg daily) and will receive
plerixafor (240 µg/kg) on each day prior to apheresis. Participants will be apheresed for
up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6
cells/kg). After apheresis, all participants will be treated with high dose chemotherapy in
preparation for transplantation. Participants will be transplanted with cells obtained from
the G-CSF plus plerixafor mobilization regimen. In the event that a sufficient number of
cells for transplantation are not obtained from the collection, cells may be retained and
pooled for transplantation at the investigator's discretion.

The primary endpoint is the proportion of HD participants who collect ≥5*10^6 CD34+ cells/kg
with this mobilization regimen. The secondary endpoints include the safety of this
mobilization regimen, the proportion of participants who collect ≥2*10^6 CD34+ cells/kg, the
change in CD34+ cells circulating in the peripheral blood after a dose of plerixafor, and
the number of days of apheresis required to obtain ≥5*10^6 CD34+ cells/kg. In addition,
success of the transplantation will be evaluated by measuring the time to engraftment of
PMNs and PLTs. Participants will be followed for 12 months to assess transplant durability.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Inclusion Criteria:

- Diagnosis of HD eligible for autologous transplantation

- No more than 3 prior regimens of chemotherapy (Rituximab is not considered
chemotherapy for the purpose of this study.)

- 4 weeks since last cycle of chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- The patient has recovered from all acute toxic effects of prior chemotherapy

- White blood cell count (WBC) >3.0*10^9/L

- Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L

- Platelet (PLT) count >100*10^9/L

- Serum creatinine ≤2.2 mg/DL

- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase
(SGPT) and total bilirubin <2 x upper limit of normal (ULN)

- Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated
acquisition (MUGA) scan

- Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or
diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted

- Negative for human immunodeficiency virus (HIV)

Exclusion Criteria:

- A co-morbid condition which, in the view of the investigator, renders the patient at
high risk for treatment complications

- Patients who have failed previous collections

- A residual acute medical condition resulting from prior chemotherapy

- Hodgkin's disease involving the central nervous system

- Acute infection

- Fever (temp >38°C/100.4°F)

- Patients whose actual body weight exceeds 150% of their ideal body weight

- History of ventricular arrhythmias

- History of paresthesias

- Patients who previously received experimental therapy within 4 weeks of enrolling in
this study or who are currently enrolled in another experimental study during the
mobilization period

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF

Outcome Description:

The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.

Outcome Time Frame:

Day 5 up to Day 9

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

January 2008

Related Keywords:

  • Hodgkin's Disease
  • Hodgkin's Disease
  • Stem cell mobilization
  • apheresis
  • Hodgkin Disease



Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia St Louis, Missouri  63110-1093