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

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

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Key information

Conditions

Hodgkin's Disease Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Multiple Myelomas Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin Lymphomas Paraproteinemias Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lenograstim

Drug

Primary outcomes

Incidence of infections
Time to platelet engraftment

Sponsors and collaborators

Lead sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Other

Collaborators

Chugai Pharma GmbH
Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Acronym: CU01

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Mar 11, 2010
Registry last updated: Mar 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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