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

Phase 2
18 Years
70 Years
Not Enrolling
Peripheral T-Cell Lymphoma

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy

Outcome Description:

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

Outcome Time Frame:

average of 24 weeks (treatment duration)

Safety Issue:


Principal Investigator

Lorenz Truemper

Investigator Role:

Principal Investigator

Investigator Affiliation:

German High Grade Non Hodgkin´s Lymphoma Study Group


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

July 2003

Completion Date:

February 2011

Related Keywords:

  • Peripheral T-cell Lymphoma
  • peripheral T cell lymphoma
  • alemtuzumab
  • consolidation
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral