CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

Study Overview
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Brief Summary
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Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Detailed Description
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Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

Official Title
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Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Conditions
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Peripheral T-Cell Lymphoma

Intervention / Treatment
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* Drug: Alemtuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all risk groups in international prognostic index diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment. these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%) written consent of the patient Declaration of center participation Exclusion Criteria: Already initiated lymphoma therapy(exept for the prephase treatment specified for this study) Serious accompanying disorder or impaired organ function bone marrow involvement>25% Known hypersensitivity to medications to be used Know HIV-positivity Active hepatitis infection, active CMV infection, prior florid tuberculosis floride systemic infections suspicion that patient compliance will be poor Simultaneous participation in any the study protocol prior chemo-or radiotherapy for malignancy other concomitant malignant disease Pregnancy or lactation period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alemtuzumab, antibody<br>alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg | Drug: Alemtuzumab<br>* Consolidation after CHOP induction<br>* Other names: MabCampath;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy | A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab | average of 24 weeks (treatment duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of complete remissions |  | at week 24 after initiation | 
| Overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral T cell lymphoma, alemtuzumab, consolidation