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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
July 25, 2008
July 30, 2008
May 7, 2012
February 2008
March 2014   (Final data collection date for primary outcome measure)
Event free survival [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00725231 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate of complete and partial remissions [ Time Frame: End of treatment ]
  • treatment related deaths [ Time Frame: time of occurence ]
  • Overall survival [ Time Frame: time of occurence ]
  • protocol adherence [ Time Frame: treatment course ]
  • immune reconstitution after alemtuzumab CHOP [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Peripheral T Cell Lymphoma, Unspecified
  • Angioimmunoblastic Lymphadenopathy
  • Extranodal NK/T-cell Lymphoma
  • 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
  • Active Comparator: Arm A
    Chemotherapy with dose dense CHOP-14, 6 cycles
    Intervention: Drug: chemotherapy
  • Experimental: Arm B
    Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
    Interventions:
    • Biological: alemtuzumab
    • Drug: chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
274
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
61 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00725231
DSHNHL 2006-1B / ACT-2
BMBF GFVT 01014715
Yes
Not Provided
Not Provided
Prof. Dr. Lorenz Trümper, University of Göttingen
University of Göttingen
  • German High-Grade Non-Hodgkin's Lymphoma Study Group
  • Nordic Lymphoma Group
Principal Investigator: Lorenz H Trümper, MD University of Göttingen
University of Göttingen
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP