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

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

Timeline

Start

2003-05

Primary completion

2004-12

Completion

2004-12

Publications

• Straka C, Sandherr M, Salwender H, Wandt H, Metzner B, Hubel K, Silling G, Hentrich M, Franke D, Schwerdtfeger R, Freund M, Sezer O, Giagounidis A, Ehninger G, Grimminger W, Engert A, Schlimok G, Scheid C, Hellmann P, Heinisch H, Einsele H, Hinke A, Emmerich B. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy. Blood. 2011 Feb 17;117(7):2121-8. doi: 10.1182/blood-2010-06-290080. Epub 2010 Dec 16.

Drugs

Indications