Overview

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

Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators:
Chugai Pharma GmbH
Ludwig-Maximilians - University of Munich
Treatments:
Lenograstim
Criteria
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