- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00725231
Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP (A-CHOP-14)
May 4, 2012 updated by: Prof. Dr. Lorenz Trümper, University of Göttingen
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
274
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lorenz H Trümper, MD
- Phone Number: 8535 +49 551 398535
- Email: lorenz.truemper@med.uni-goettingen.de
Study Contact Backup
- Name: Gerald G Wulf, MD
- Phone Number: 6303 +49 551 396303
- Email: gwulf@med.uni-goettingen.de
Study Locations
-
-
Lower Saxony
-
Göttingen, Lower Saxony, Germany, 37099
- Recruiting
- University of Göttingen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
61 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm A
Chemotherapy with dose dense CHOP-14, 6 cycles
|
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Names:
|
EXPERIMENTAL: Arm B
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
|
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Other Names:
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Event free survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of complete and partial remissions
Time Frame: 4 months after inclusion
|
4 months after inclusion
|
treatment related deaths
Time Frame: time of occurence
|
time of occurence
|
Overall survival
Time Frame: @ 3 years
|
@ 3 years
|
protocol adherence
Time Frame: 4 months of treatment
|
4 months of treatment
|
immune reconstitution after alemtuzumab CHOP
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lorenz H Trümper, MD, University of Göttingen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ANTICIPATED)
March 1, 2014
Study Completion (ANTICIPATED)
March 1, 2014
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 25, 2008
First Posted (ESTIMATE)
July 30, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 7, 2012
Last Update Submitted That Met QC Criteria
May 4, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Extranodal NK-T-Cell
- Immunoblastic Lymphadenopathy
- Lymphadenopathy
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
- Alemtuzumab
Other Study ID Numbers
- DSHNHL 2006-1B / ACT-2
- BMBF GFVT 01014715
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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