Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP (A-CHOP-14)

May 4, 2012 updated by: Prof. Dr. Lorenz Trümper, University of Göttingen

Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly

Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37099
        • Recruiting
        • University of Göttingen

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

61 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all risk groups of peripheral T cell lymphoma
  • performance status ECOG 0-2
  • written consent
  • measurable disease

Exclusion Criteria:

  • stage I N without bulky disease
  • already initiated treatment
  • serious accompanying disorder or impaired organ function
  • bone marrow involvement >25%
  • HIV positivity
  • leukemic manifestation of lymphoma
  • simultaneous participation in another trial
  • platelets < 100 000/ mm, leukocytes < 2500 /mm

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm A
Chemotherapy with dose dense CHOP-14, 6 cycles
Drug: chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Names:
  • chemotherapy cylcophosphamide, hydroxyldaunorubicin
EXPERIMENTAL: Arm B
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
Drug: chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Names:
  • chemotherapy cylcophosphamide, hydroxyldaunorubicin
Biological: alemtuzumab
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
Other Names:
  • monoclonal anti CD52 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of complete and partial remissions
Time Frame: 4 months after inclusion
4 months after inclusion
treatment related deaths
Time Frame: time of occurence
time of occurence
Overall survival
Time Frame: @ 3 years
@ 3 years
protocol adherence
Time Frame: 4 months of treatment
4 months of treatment
immune reconstitution after alemtuzumab CHOP
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

University of Göttingen

Collaborators

Nordic Lymphoma Group
German High-Grade Non-Hodgkin's Lymphoma Study Group

Investigators

  • Principal Investigator: Lorenz H Trümper, MD, University of Göttingen

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

February 1, 2008

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSHNHL 2006-1B / ACT-2
  • BMBF GFVT 01014715

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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