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Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy

2014-08-27 03:15:18 | BioPortfolio

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Hodgkin's Disease

Intervention

lenograstim

Status

Completed

Source

WiSP Wissenschaftlicher Service Pharma GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:18-0400

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