Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Phase | Type | Status | Age | Sponsor | Protocol IDs |
---|---|---|---|---|---|
Phase III | Treatment | Active | 61 to 80 | Other | DSHNHL 2006-1B / ACT-2 BMBF GFVT 01014715, NCT00725231 |
Summary
Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.
Eligibility Criteria
Inclusion Criteria:
- all risk groups of peripheral T cell lymphoma
- performance status ECOG 0-2
- written consent
- measurable disease
Exclusion Criteria:
- stage I N without bulky disease
- 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
Trial Lead Organizations/Sponsors
Universitaetsklinikum Goettingen
German High-Grade Non-Hodgkin's Lymphoma Study GroupNordic Lymphoma Group
L. Trumper | Principal Investigator |
Lorenz H Trümper, MD | Ph: +49 551 398535 Ext.8535 | |
Email: lorenz.truemper@med.uni-goettingen.de |
Trial Sites
Germany | |||
Göttingen | |||
Universitaetsklinikum Goettingen | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00725231
Information obtained from ClinicalTrials.gov on May 06, 2012
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