Overview
CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma
Status:
Completed
Completed
Trial end date:
2011-02-01
2011-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab ConsolidationPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of GöttingenTreatments:
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