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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
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00725231
First received: July 25, 2008
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  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
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:

MedlinePlus related topics: Lymphoma
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: 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

  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
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: 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
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
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoma, Non-Hodgkin
 Doxorubicin
Alemtuzumab
Campath 1G
Antibodies, Neoplasm
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013