Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly

Conditions
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Peripheral T Cell Lymphoma, Unspecified, Angioimmunoblastic Lymphadenopathy, Extranodal NK/T-cell Lymphoma

Intervention / Treatment
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* Biological: alemtuzumab
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 61 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Chemotherapy with dose dense CHOP-14, 6 cycles | Drug: chemotherapy<br>* dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF<br>* Other names: chemotherapy cylcophosphamide, hydroxyldaunorubicin;|
| Experimental: Arm B<br>Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles | Biological: alemtuzumab<br>* Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles<br>* Other names: monoclonal anti CD52 antibody;Drug: chemotherapy<br>* dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF<br>* Other names: chemotherapy cylcophosphamide, hydroxyldaunorubicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete and partial remissions |  | 4 months after inclusion | 
| treatment related deaths |  | time of occurence | 
| Overall survival |  | @ 3 years | 
| protocol adherence |  | 4 months of treatment | 
| immune reconstitution after alemtuzumab CHOP |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T cell lymphoma