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

Sponsor:	University of Göttingen
Collaborators:	German High-Grade Non-Hodgkin's Lymphoma Study Group Nordic Lymphoma Group
Information provided by:	University of Göttingen
ClinicalTrials.gov Identifier:	NCT00725231

Purpose

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.

Condition	Intervention	Phase
Peripheral T Cell Lymphoma, Unspecified Angioimmunoblastic Lymphadenopathy AIL Type Lymphoma Anaplastic Large Cell Lymphoma, ALK Negative Extranodal NK/T-Cell Lymphoma	Biological: alemtuzumab Drug: chemotherapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-Cell Lymphoma of the Elderly

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Doxorubicin Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by University of Göttingen:

Primary Outcome Measures:

Event free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of complete and partial remissions [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
treatment related deaths [ Time Frame: time of occurence ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: time of occurence ] [ Designated as safety issue: Yes ]
protocol adherence [ Time Frame: treatment course ] [ Designated as safety issue: Yes ]
immune reconstitution after alemtuzumab CHOP [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	274
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Active Comparator Chemotherapy with dose dense CHOP-14, 6 cycles	Drug: chemotherapy dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Arm B: Experimental Chemotherapy with dose dense CHOP-14, 6-cycles, together with 60 mg Alemtuzumab s.c. per cycle	Biological: alemtuzumab Addition of 60 mg / sq m Alemtuzumab by subcutaneous application Drug: chemotherapy dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Eligibility

Ages Eligible for Study:	61 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725231

Contacts

Contact: Lorenz H Trümper, MD	+49 551 398535 ext 8535	lorenz.truemper@med.uni-goettingen.de
Contact: Gerald G Wulf, MD	+49 551 396303 ext 6303	gwulf@med.uni-goettingen.de

Locations

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

Sponsors and Collaborators

University of Göttingen

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

Nordic Lymphoma Group

Investigators

Principal Investigator:

Lorenz H Trümper, MD

University of Göttingen

More Information

Additional Information:

main site of German lymphoma trial groups This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dean, University Medicine Goettingen ( Professor Dr Cornelius Froemmel )
Study ID Numbers:	DSHNHL 2006-1B / ACT-2, BMBF GFVT 01014715
Study First Received:	July 25, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00725231 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by University of Göttingen:

T cell lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, B-Cell
Lymphoma, Large-Cell, Anaplastic
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents
Immunoblastic Lymphadenopathy
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Alemtuzumab
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 09, 2010