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

March 6, 2013 updated by: Lorenz, Trümper, MD, University of Göttingen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alemtuzumab, antibody
alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg
Drug: Alemtuzumab
Consolidation after CHOP induction
Other Names:
  • MabCampath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
average of 24 weeks (treatment duration)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
rate of complete remissions
Time Frame: at week 24 after initiation
at week 24 after initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Investigators

  • Principal Investigator: Lorenz Truemper, German High Grade Non Hodgkin´s Lymphoma Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSHNHL-2003-1
  • German High Grade Lymphoma SG (Other Identifier: DSHNHL)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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