Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
NCT ID: NCT00725231
Last Updated: 2012-05-07
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
PHASE3
274 participants
INTERVENTIONAL
2008-02-29
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Chemotherapy with dose dense CHOP-14, 6 cycles
chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Arm B
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
alemtuzumab
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Interventions
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alemtuzumab
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* performance status ECOG 0-2
* written consent
* measurable disease
Exclusion Criteria
* already initiated treatment
* serious accompanying disorder or impaired organ function
* bone marrow involvement \>25%
* HIV positivity
* leukemic manifestation of lymphoma
* simultaneous participation in another trial
* platelets \< 100 000/ mm, leukocytes \< 2500 /mm
61 Years
80 Years
ALL
No
Sponsors
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German High-Grade Non-Hodgkin's Lymphoma Study Group
OTHER
Nordic Lymphoma Group
NETWORK
University of Göttingen
OTHER
Responsible Party
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Prof. Dr. Lorenz Trümper
Head of Departement of Haemtology and Oncology
Principal Investigators
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Lorenz H Trümper, MD
Role: PRINCIPAL_INVESTIGATOR
University of Göttingen
Locations
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University of Göttingen
Göttingen, Lower Saxony, Germany
Countries
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Central Contacts
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Other Identifiers
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BMBF GFVT 01014715
Identifier Type: -
Identifier Source: secondary_id
DSHNHL 2006-1B / ACT-2
Identifier Type: -
Identifier Source: org_study_id
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