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

This study is currently recruiting participants.
Verified May 2012 by University of Göttingen
German High-Grade Non-Hodgkin's Lymphoma Study Group
Nordic Lymphoma Group
Information provided by (Responsible Party):
Prof. Dr. Lorenz Trümper, University of Göttingen Identifier:
First received: July 25, 2008
Last updated: May 4, 2012
Last verified: May 2012

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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: 4 months after inclusion ] [ Designated as safety issue: No ]
  • treatment related deaths [ Time Frame: time of occurence ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: @ 3 years ] [ Designated as safety issue: Yes ]
  • protocol adherence [ Time Frame: 4 months of treatment ] [ 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
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


Ages Eligible for Study:   61 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT00725231

Contact: Lorenz H Trümper, MD +49 551 398535 ext 8535
Contact: Gerald G Wulf, MD +49 551 396303 ext 6303

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:
No publications provided

Responsible Party: Prof. Dr. Lorenz Trümper, Head of Departement of Haemtology and Oncology, University of Göttingen Identifier: NCT00725231     History of Changes
Other Study ID Numbers: DSHNHL 2006-1B / ACT-2, BMBF GFVT 01014715
Study First Received: July 25, 2008
Last Updated: May 4, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University of Göttingen:
T cell lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Immunoblastic Lymphadenopathy
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Lymphoma, Non-Hodgkin
Campath 1G
Antibodies, Neoplasm
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 17, 2014