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
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: A: lenograstim
total group
|
Drug: lenograstim |
- Incidence of infections
- Time to platelet engraftment

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