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

Phase 2

Completed

• Conditions: Hodgkin's Disease; Non-Hodgkin Lymphomas; Multiple Myelomas
• Interventions: Drug: lenograstim

• Registration Number: NCT01085058
• Lead Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Status Verified: 2010-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Last Update Submitted: 2010-03-10
• Study First Posted: 2010-03-11
• Last Update Posted: 2010-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A: lenograstim	lenograstim	total group

Primary Outcome Measures

Name	Time	Method
Incidence of infections
Time to platelet engraftment