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| ID | Type | Description | Link |
|---|---|---|---|
| BMBF GFVT 01014715 |
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| Name | Class |
|---|---|
| German High-Grade Non-Hodgkin's Lymphoma Study Group | OTHER |
| Nordic Lymphoma Group | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Chemotherapy with dose dense CHOP-14, 6 cycles |
|
| Arm B | Experimental | Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological | Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete and partial remissions | 4 months after inclusion | |
| treatment related deaths | time of occurence | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenz H Trümper, MD | Contact | +49 551 398535 | 8535 | lorenz.truemper@med.uni-goettingen.de |
| Gerald G Wulf, MD | Contact | +49 551 396303 | 6303 | gwulf@med.uni-goettingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Lorenz H Trümper, MD | University of Göttingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Göttingen | Recruiting | Göttingen | Lower Saxony | 37099 | Germany |
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| chemotherapy | Drug | dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF |
|
|
| @ 3 years |
| protocol adherence | 4 months of treatment |
| immune reconstitution after alemtuzumab CHOP | 3 years |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D007119 | Immunoblastic Lymphadenopathy |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D004358 | Drug Therapy |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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