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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01085058

Acronym

CU01

Enrollment

169

Registered

2010-03-11

Start date

2003-05-31

Completion date

2004-12-31

Last updated

2010-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy

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

Interventions

DRUGlenograstim

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of infections	—
Time to platelet engraftment	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026