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Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP (A-CHOP-14)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Prof. Dr. Lorenz Trümper, University of Göttingen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725231
First Posted: July 30, 2008
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German High-Grade Non-Hodgkin's Lymphoma Study Group
Nordic Lymphoma Group
Information provided by (Responsible Party):
Prof. Dr. Lorenz Trümper, University of Göttingen
  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. 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.

Condition Intervention Phase
Peripheral T Cell Lymphoma, Unspecified Angioimmunoblastic Lymphadenopathy Extranodal NK/T-cell Lymphoma Biological: alemtuzumab Drug: chemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Prof. Dr. Lorenz Trümper, University of Göttingen:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Rate of complete and partial remissions [ Time Frame: 4 months after inclusion ]
  • treatment related deaths [ Time Frame: time of occurence ]
  • Overall survival [ Time Frame: @ 3 years ]
  • protocol adherence [ Time Frame: 4 months of treatment ]
  • immune reconstitution after alemtuzumab CHOP [ Time Frame: 3 years ]

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
Active Comparator: Arm A
Chemotherapy with dose dense CHOP-14, 6 cycles
Drug: chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Name: chemotherapy cylcophosphamide, hydroxyldaunorubicin
Experimental: Arm B
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
Biological: alemtuzumab
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
Other Name: monoclonal anti CD52 antibody
Drug: chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Name: chemotherapy cylcophosphamide, hydroxyldaunorubicin

  Eligibility

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Ages Eligible for Study:   61 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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:
Responsible Party: Prof. Dr. Lorenz Trümper, Head of Departement of Haemtology and Oncology, University of Göttingen
ClinicalTrials.gov Identifier: NCT00725231     History of Changes
Other Study ID Numbers: DSHNHL 2006-1B / ACT-2
BMBF GFVT 01014715
First Submitted: July 25, 2008
First Posted: July 30, 2008
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Prof. Dr. Lorenz Trümper, University of Göttingen:
T cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell
Lymphadenopathy
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Alemtuzumab
Antineoplastic Agents