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Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy (CU01)

This study has been completed.
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
Chugai Pharma GmbH
Information provided by:
WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01085058
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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

Condition Intervention Phase
Hodgkin's Disease
Non-Hodgkin Lymphomas
Multiple Myelomas
 Drug: lenograstim
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by WiSP Wissenschaftlicher Service Pharma GmbH:

Primary Outcome Measures:
  • Incidence of infections
  • Time to platelet engraftment

Enrollment: 169
Study Start Date: May 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: lenograstim
total group
 Drug: lenograstim

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by WiSP Wissenschaftlicher Service Pharma GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Christian Straka, Univ. of Munich (LMU)
ClinicalTrials.gov Identifier: NCT01085058     History of Changes
Other Study ID Numbers: WISP_CU01
Study First Received: March 10, 2010
Last Updated: March 10, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by WiSP Wissenschaftlicher Service Pharma GmbH:
Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
 Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013