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
78 participants
INTERVENTIONAL
2007-01-31
2013-08-31
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
Study Groups
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A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
methotrexate
8000mg/m2 i.v., max. 2 cycles
Rituximab
375mg/m2, max. 8 times
Cytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Thiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Carmustin
400mg/m2 i.v. for 1 day
B
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
Rituximab
375mg/m2, max. 8 times
Cytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Thiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Carmustin
400mg/m2 i.v. for 1 day
Interventions
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methotrexate
8000mg/m2 i.v., max. 2 cycles
Rituximab
375mg/m2, max. 8 times
Cytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Thiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Carmustin
400mg/m2 i.v. for 1 day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* group B: relapse or progression of PCNSL after MTX containing chemotherapy
* age 18 - 65 years
* not legally incompetent, physically or mentally incapable of giving consent
* 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
* neutrophil count \< 2.000/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)
* pregnancy o r lactation
* women with childbearing potential without sufficient contraception
* 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
* known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
University Hospital Freiburg
OTHER
Responsible Party
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University Hospital Freiburg
Principal Investigators
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Jürgen Finke, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Locations
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University Hospital Freiburg
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, Ihorst G, Guttenberger R, Ostertag C, Derigs G, Frickhofen N, Feuerhake F, Volk B, Finke J. High-dose chemotherapy with autologous stem-cell transplantation and hyperfractionated radiotherapy as first-line treatment of primary CNS lymphoma. J Clin Oncol. 2006 Aug 20;24(24):3865-70. doi: 10.1200/JCO.2006.06.2117. Epub 2006 Jul 24.
Kasenda B, Ihorst G, Schroers R, Korfel A, Schmidt-Wolf I, Egerer G, von Baumgarten L, Roth A, Bloehdorn J, Mohle R, Binder M, Keller U, Lamprecht M, Pfreundschuh M, Valk E, Fricker H, Schorb E, Fritsch K, Finke J, Illerhaus G. High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group. Leukemia. 2017 Dec;31(12):2623-2629. doi: 10.1038/leu.2017.170. Epub 2017 May 31.
Illerhaus G, Kasenda B, Ihorst G, Egerer G, Lamprecht M, Keller U, Wolf HH, Hirt C, Stilgenbauer S, Binder M, Hau P, Edinger M, Frickhofen N, Bentz M, Mohle R, Roth A, Pfreundschuh M, von Baumgarten L, Deckert M, Hader C, Fricker H, Valk E, Schorb E, Fritsch K, Finke J. High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol. 2016 Aug;3(8):e388-97. doi: 10.1016/S2352-3026(16)30050-3. Epub 2016 Jul 13.
Other Identifiers
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ZNS-00465
Identifier Type: -
Identifier Source: org_study_id
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