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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive61 to 80OtherDSHNHL 2006-1B / ACT-2
BMBF GFVT 01014715, NCT00725231

Trial Description

Summary

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitaetsklinikum Goettingen

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

Nordic Lymphoma Group

L. TrumperPrincipal Investigator

Lorenz H Trümper, MDPh: +49 551 398535 Ext.8535
  Email: lorenz.truemper@med.uni-goettingen.de

Trial Sites

Germany
  Göttingen
 Universitaetsklinikum Goettingen

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00725231
Information obtained from ClinicalTrials.gov on May 06, 2012

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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