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

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ClinicalTrials.gov Identifier: NCT01085058
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 11, 2010
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
Chugai Pharma GmbH
Information provided by:
WiSP Wissenschaftlicher Service Pharma GmbH

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A: lenograstim
total group
 Drug: lenograstim


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of infections
  2. Time to platelet engraftment

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Christian Straka, Univ. of Munich (LMU)
ClinicalTrials.gov Identifier: NCT01085058    
Other Study ID Numbers: WISP_CU01
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: March 2010
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:
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Multiple Myeloma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoproliferative Disorders
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs