Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators:
Chugai Pharma GmbH Ludwig-Maximilians - University of Munich