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

NCT00725231 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2012-05-07

No results posted yet for this study

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.

Conditions

  • Peripheral T Cell Lymphoma, Unspecified
  • Angioimmunoblastic Lymphadenopathy
  • Extranodal NK/T-cell Lymphoma

Interventions

BIOLOGICAL

alemtuzumab

Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles

DRUG

chemotherapy

dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Sponsors & Collaborators

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

    collaborator OTHER

  • Nordic Lymphoma Group

    collaborator NETWORK

  • University of Göttingen

    lead OTHER

Principal Investigators

  • Lorenz H Trümper, MD · University of Göttingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
61 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00725231 on ClinicalTrials.gov