Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp online chat

	NCI Highlights


	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

	Related Links


	Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 61 to 80 Other DSHNHL 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. We 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. Trumper

Principal Investigator

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

Gerald G Wulf, MD		Ph: +49 551 396303 Ext.6303
		Email: gwulf@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 March 18, 2009

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.