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

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ClinicalTrials.gov Identifier: NCT00725231
Recruitment Status : Unknown
Verified May 2012 by Prof. Dr. Lorenz Trümper, University of Göttingen.
Recruitment status was:  Recruiting
First Posted : July 30, 2008
Last Update Posted : May 7, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
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
Study Start Date : February 2008
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   61 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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
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 Posted: July 30, 2008    Key Record Dates
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, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents