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Predictive Value of the "Cytocapacity Test" Following a Single-dose of rHu-G-CSF in Patients With Lymphoproliferative Diseases and High-dose Therapy
This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic study. Patients who received high-dose therapy with autologous stem cell transplantation for the treatment of their lymphoproliferative disease were included into the study. After completion of the high-dose therapy (day -2 with respect to the stem cell transplantation) the first blood sample A for the cytocapacity test with determination of leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study medication was administered. The second blood sample B for the cytocapacity test with determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours after administration of the study medication. Thereafter the stem cell re-infusion was performed. The primary objective of this study was to show that the cytocapacity test with lenograstim is a useful predictive tool with respect to the risk of post-transplant complications and prolonged myelosuppression, typically occurring after high-dose chemotherapy. The primary variables were: * the rate of patients with documented infections * the time to platelet engraftment
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Start Date
May 1, 2003
Primary Completion Date
December 1, 2004
Completion Date
December 1, 2004
Last Updated
March 11, 2010
169
ACTUAL participants
lenograstim
DRUG
Lead Sponsor
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators
NCT05346809
NCT05595447
Data Source & Attribution
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