AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

Completed · Phase 2

Conditions studied: Hodgkin's Disease

In brief

Participants with Hodgkin's Disease (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 efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5\*10\^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

Key facts

Study ID

NCT00396201

Run by

Genzyme, a Sanofi Company

People needed

22

Starts

2004-11-01

Expected to finish

2008-01-01

Last updated by the study team

2014-03-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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