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

Hodgkin's Disease Clinical Trial

— CU01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085058
• Other study ID #: WISP_CU01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 10, 2010
• Last updated: March 10, 2010
• Start date: May 2003
• Est. completion date: December 2004

Study information

• Verified date: March 2010
• Source: WiSP Wissenschaftlicher Service Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma, Non-Hodgkin
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myelomas
• Neoplasms, Plasma Cell
• Non-Hodgkin Lymphomas

Intervention

Drug:
• lenograstim

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
WiSP Wissenschaftlicher Service Pharma GmbH	Chugai Pharma GmbH, Ludwig-Maximilians - University of Munich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infections
Primary	Time to platelet engraftment