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