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Completed

NCT Number: NCT01806337

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

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

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alemtuzumab

Drug

Consolidation after CHOP induction

Other names: MabCampath

Primary outcomes

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

    Time frame: 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 outcomes

  1. rate of complete remissions

    Time frame: at week 24 after initiation

  2. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2011
First posted
Mar 7, 2013
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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