Status:
COMPLETED
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
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Hodgkin's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 ente...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00396201
Start Date
November 1 2004
End Date
January 1 2008
Last Update
March 13 2014
Active Locations (1)
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1
Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia
St Louis, Missouri, United States, 63110-1093