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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00725231
Other study ID # DSHNHL 2006-1B / ACT-2
Secondary ID BMBF GFVT 010147
Status Recruiting
Phase Phase 3
First received July 25, 2008
Last updated May 4, 2012
Start date February 2008
Est. completion date March 2014

Study information

Verified date May 2012
Source University of Göttingen
Contact Lorenz H Trümper, MD
Phone +49 551 398535
Email lorenz.truemper@med.uni-goettingen.de
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 274
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 61 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany University of Göttingen Göttingen Lower Saxony

Sponsors (3)

Lead Sponsor Collaborator
University of Göttingen German High-Grade Non-Hodgkin's Lymphoma Study Group, Nordic Lymphoma Group

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event free survival 3 years No
Secondary Rate of complete and partial remissions 4 months after inclusion No
Secondary treatment related deaths time of occurence Yes
Secondary Overall survival @ 3 years Yes
Secondary protocol adherence 4 months of treatment Yes
Secondary immune reconstitution after alemtuzumab CHOP 3 years Yes
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