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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor

Criteria

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