Hodgkin's Disease Clinical Trial
Official title:
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
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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