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

Phase 2

Completed

• Conditions: Peripheral T-Cell Lymphoma
• Interventions: Drug: Alemtuzumab

• Registration Number: NCT01806337
• Lead Sponsor: University of Göttingen

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-07
• Study Completion: 2011-02
• Study First Submitted: 2013-02-25
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-06
• Last Update Submitted: 2013-03-06
• Study First Posted: 2013-03-07
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alemtuzumab, antibody	Alemtuzumab	alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg

Primary Outcome Measures

Name	Time	Method
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy	average of 24 weeks (treatment duration)	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

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years
rate of complete remissions	at week 24 after initiation