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

Study Overview
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Brief Summary
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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

Official Title
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Predictive Value of the Cytocapacity Test Following a Single-dose of rHu-G-CSF in Patients With Lymphoproliferative Diseases and High-dose Therapy

Conditions
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Hodgkin's Disease, Non-Hodgkin Lymphomas, Multiple Myelomas

Intervention / Treatment
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* Drug: lenograstim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of histologically proven lymphoproliferative disease specified as Hodgkin's disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma Indication of high-dose therapy and autologous peripheral blood stem cell transplantation Availability of a sufficient amount of blood stem cells (CD34+ cells >= 2.0 x 106/kg) Age between 18 and 70 years High-dose therapy with one of the following high-dose regimes: Melphalan 140 mg/m2 or 200 mg/m2, BEAM, BEAC, BUCY or CBV (the last permitted according to amendment 2, see Section 9.8.1) Patient's written consent to participation in this trial Exclusion Criteria: Previous high-dose therapy and blood stem cell transplantation except for melphalan 140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in the cytocapacity test previously (according to amendment 2, see Section 9.8.1). Known intolerance to lenograstim Out-patient therapy following high-dose therapy and blood stem cell transplantation Myocardial infarction < 6 months prior to inclusion into the study Cardiac arrhythmias Lown IV b Clinically manifest cardiac insufficiency (> NYHA II) Renal insufficiency with serum creatinine > 2 mg% Hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal Severe infections (HIV, Hepatitis B/C) Severe psychiatric diseases Non-curative treatment of other malignoma within the past 5 years Pregnant women or women breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: lenograstim<br>total group | Drug: lenograstim<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infections |  |  | 
| Time to platelet engraftment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy