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


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Both
Hodgkin's Disease, Non-Hodgkin Lymphomas, Multiple Myelomas

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of infections

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

WISP_CU01

NCT ID:

NCT01085058

Start Date:

May 2003

Completion Date:

December 2004

Related Keywords:

  • Hodgkin's Disease
  • Non-Hodgkin Lymphomas
  • Multiple Myelomas
  • Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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