Overview

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

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
Summary
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Göttingen
Treatments:
Alemtuzumab
Criteria
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