Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01085058
Status:
COMPLETED
Last Update Posted:
2010-03-11
First Post:
2010-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078224', 'term': 'Lenograstim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-10', 'studyFirstSubmitDate': '2010-03-10', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infections'}, {'measure': 'Time to platelet engraftment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy"], 'conditions': ["Hodgkin's Disease", 'Non-Hodgkin Lymphomas', 'Multiple Myelomas']}, 'referencesModule': {'references': [{'pmid': '21163927', 'type': 'DERIVED', 'citation': 'Straka C, Sandherr M, Salwender H, Wandt H, Metzner B, Hubel K, Silling G, Hentrich M, Franke D, Schwerdtfeger R, Freund M, Sezer O, Giagounidis A, Ehninger G, Grimminger W, Engert A, Schlimok G, Scheid C, Hellmann P, Heinisch H, Einsele H, Hinke A, Emmerich B. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy. Blood. 2011 Feb 17;117(7):2121-8. doi: 10.1182/blood-2010-06-290080. Epub 2010 Dec 16.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAfter 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.\n\nThe 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.\n\nThe primary variables were:\n\n* the rate of patients with documented infections\n* the time to platelet engraftment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of histologically proven lymphoproliferative disease specified as Hodgkin's disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma\n* Indication of high-dose therapy and autologous peripheral blood stem cell transplantation\n* Availability of a sufficient amount of blood stem cells (CD34+ cells \\>= 2.0 x 106/kg)\n* Age between 18 and 70 years\n* 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)\n* Patient's written consent to participation in this trial\n\nExclusion Criteria:\n\n* 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).\n* Known intolerance to lenograstim\n* Out-patient therapy following high-dose therapy and blood stem cell transplantation\n* Myocardial infarction \\< 6 months prior to inclusion into the study\n* Cardiac arrhythmias Lown IV b\n* Clinically manifest cardiac insufficiency (\\> NYHA II)\n* Renal insufficiency with serum creatinine \\> 2 mg%\n* Hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal\n* Severe infections (HIV, Hepatitis B/C)\n* Severe psychiatric diseases\n* Non-curative treatment of other malignoma within the past 5 years\n* Pregnant women or women breast-feeding"}, 'identificationModule': {'nctId': 'NCT01085058', 'acronym': 'CU01', 'briefTitle': 'Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy', 'organization': {'class': 'OTHER', 'fullName': 'WiSP Wissenschaftlicher Service Pharma GmbH'}, 'officialTitle': 'Predictive Value of the "Cytocapacity Test" Following a Single-dose of rHu-G-CSF in Patients With Lymphoproliferative Diseases and High-dose Therapy', 'orgStudyIdInfo': {'id': 'WISP_CU01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: lenograstim', 'description': 'total group', 'interventionNames': ['Drug: lenograstim']}], 'interventions': [{'name': 'lenograstim', 'type': 'DRUG', 'armGroupLabels': ['A: lenograstim']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WiSP Wissenschaftlicher Service Pharma GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Chugai Pharma GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr. Christian Straka', 'oldOrganization': 'Univ. of Munich (LMU)'}}}}