Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
NCT ID: NCT00989352
Last Updated: 2009-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
56 participants
INTERVENTIONAL
2009-09-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Methotrexate
3g/m² i.v. max. 9 times
Lomustine
110 mg/m² p.o., max. 3 times
Procarbazine
60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
Rituximab
375 mg/m² i.v., max. 10 times
Eligibility Criteria
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Inclusion Criteria
* age \> 65 years
* written signed and dated informed consent of the legal representative and - if possible - of the patient
Exclusion Criteria
* sero-positive for HIV
* severe pulmonary, cardiac, hepatic, renal impairment
* uncontrolled infection
* neutrophil count \< 1.500/µl, platelet count \< 100.000/µl
* pulmonary disease with IVC \< 55%, DLCO \< 40%
* cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia
* creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min
* bilirubin \> 2mg/dl
* ascites or pleural effusion (\> 500ml)
* known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
* participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
* known or current drug or alcohol abuse
65 Years
ALL
No
Sponsors
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Universitätsklinikum Köln
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University Hospital Heidelberg
OTHER
University Hospital Ulm
OTHER
University Hospital Freiburg
OTHER
Responsible Party
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University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Principal Investigators
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Gerald Illerhaus, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Locations
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University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Freiburg im Breisgau, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26.
Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.
Related Links
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Related Info
Other Identifiers
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Eudract: 2008-007645-31
Identifier Type: -
Identifier Source: secondary_id
00591
Identifier Type: -
Identifier Source: org_study_id
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