Peripheral T Cell Lymphoma, UnspecifiedPhase 3A-CHOP-14NCT00725231
Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
A Phase 3 study testing alemtuzumab and chemotherapy in people with Peripheral T Cell Lymphoma, Unspecified and Angioimmunoblastic Lymphadenopathy, run by University of Göttingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 61 to 80 years
- Conditions the study is for
- Peripheral T Cell Lymphoma, Unspecified, Angioimmunoblastic Lymphadenopathy, Extranodal NK/T-cell Lymphoma
- What is being tested?
- alemtuzumab and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all risk groups of peripheral T cell lymphoma
- performance status ECOG 0-2
- written consent
- measurable disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Göttingen
Göttingen, Lower Saxony, 37099
About this study
Official title: 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.
- Conditions
- Peripheral T Cell Lymphoma, Unspecified, Angioimmunoblastic Lymphadenopathy, Extranodal NK/T-cell Lymphoma
- Being tested
- alemtuzumab, chemotherapy
- Keywords
- T cell lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabBiological
Also called monoclonal anti CD52 antibody
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
chemotherapyDrug
Also called chemotherapy cylcophosphamide, hydroxyldaunorubicin
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Chemotherapy with dose dense CHOP-14, 6 cycles Receives: Drug: chemotherapy |
| Arm B | Experimental | Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles Receives: Biological: alemtuzumab; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: 3 years
Secondary outcomes (5)
Rate of complete and partial remissions
Measured: 4 months after inclusion
treatment related deaths
Measured: time of occurence
Overall survival
Measured: @ 3 years
protocol adherence
Measured: 4 months of treatment
immune reconstitution after alemtuzumab CHOP
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell Lymphoma, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- German High-Grade Non-Hodgkin's Lymphoma Study Group, Nordic Lymphoma Group
- Responsible party
- Principal investigator, Prof. Dr. Lorenz Trümper, University of Göttingen
- Investigators
- Lorenz H Trümper, MD, Principal investigator, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725231
- Sponsor's protocol ID
- DSHNHL 2006-1B / ACT-2
- Other IDs
- BMBF GFVT 01014715
- Acronym
- A-CHOP-14
- Status last verified
- May 2012
- First submitted
- 25 Jul 2008
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
- ClinicalTrials.gov ID
- NCT00725231
- Acronym / sponsor ID
- A-CHOP-14 / DSHNHL 2006-1B / ACT-2
- Conditions
- Peripheral T Cell Lymphoma, Unspecified, Angioimmunoblastic Lymphadenopathy, Extranodal NK/T-cell Lymphoma
- Keywords
- T cell lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- German High-Grade Non-Hodgkin's Lymphoma Study Group, Nordic Lymphoma Group
- Study start
- Feb 2008
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: chemotherapyChemotherapy with dose dense CHOP-14, 6 cycles |
| Arm B | Experimental | Biological: alemtuzumab, Drug: chemotherapyChemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles |
Who may qualify
- Ages
- 61 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- all risk groups of peripheral T cell lymphoma
- performance status ECOG 0-2
- written consent
- measurable disease
Key exclusion criteria (8 listed)
- stage I N without bulky disease
- already initiated treatment
- serious accompanying disorder or impaired organ function
- bone marrow involvement >25%
- HIV positivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alemtuzumabAlso: monoclonal anti CD52 antibodyAddition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles | Biological | Arm B |
| chemotherapyAlso: chemotherapy cylcophosphamide, hydroxyldaunorubicindose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF | Drug | Arm A, Arm B |
Primary outcome
Event free survival
Time frame: 3 years
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz H Trümper, MD principal investigator
University of Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alemtuzumab and chemotherapy in people with Peripheral T Cell Lymphoma, Unspecified and Angioimmunoblastic Lymphadenopathy, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenz H Trümper, MD (+49 551 398535 ext. 8535, lorenz.truemper@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.