Status:

COMPLETED

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

Lead Sponsor:

University of Göttingen

Conditions:

Peripheral T-Cell Lymphoma

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT01806337

Start Date

July 1 2003

End Date

February 1 2011

Last Update

March 7 2013

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