Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy (CU01)
|ClinicalTrials.gov Identifier: NCT01085058|
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 11, 2010
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
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Disease Non-Hodgkin Lymphomas Multiple Myelomas||Drug: lenograstim||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
Experimental: A: lenograstim
- Incidence of infections
- Time to platelet engraftment