Peripheral T-Cell LymphomaPhase 2NCT01806337
CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma
A Phase 2 study testing Alemtuzumab in people with Peripheral T-Cell Lymphoma, run by University of Göttingen.
Trial summary
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- What is being tested?
- Alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Feb 2011
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all risk groups in international prognostic index
- diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
- these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
- Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
- written consent of the patient
- Declaration of center participation
Who cannot join
- Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
- Serious accompanying disorder or impaired organ function
- bone marrow involvement>25%
- Known hypersensitivity to medications to be used
- Know HIV-positivity
- Active hepatitis infection, active CMV infection, prior florid tuberculosis
Show all 12Show fewer
- floride systemic infections
- suspicion that patient compliance will be poor
- Simultaneous participation in any the study protocol
- prior chemo-or radiotherapy for malignancy
- other concomitant malignant disease
- Pregnancy or lactation period
About this study
Official title: Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
Read the detailed description
Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- Alemtuzumab
- Keywords
- peripheral T cell lymphoma, alemtuzumab, consolidation
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
Also called MabCampath
Consolidation after CHOP induction
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab, antibody | Experimental | alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab
Measured: average of 24 weeks (treatment duration)
Secondary outcomes (2)
rate of complete remissions
Measured: at week 24 after initiation
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startJul 2003
- Primary completionJul 2006
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-Cell LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenz, Trümper, MD, University of Göttingen
- Investigators
- Lorenz Truemper, Principal investigator, German High Grade Non Hodgkin´s Lymphoma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806337
- Sponsor's protocol ID
- DSHNHL-2003-1
- Other IDs
- German High Grade Lymphoma SG
- Status last verified
- Mar 2013
- First submitted
- 25 Feb 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
- ClinicalTrials.gov ID
- NCT01806337
- Acronym / sponsor ID
- DSHNHL-2003-1
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- peripheral T cell lymphoma, alemtuzumab, consolidation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Mar 2013 (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.
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
Detailed description
Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab, antibody | Experimental | Drug: Alemtuzumabalemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- all risk groups in international prognostic index
- diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
- these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
- Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
- written consent of the patient
Key exclusion criteria (12 listed)
- Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
- Serious accompanying disorder or impaired organ function
- bone marrow involvement>25%
- Known hypersensitivity to medications to be used
- Know 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: MabCampathConsolidation after CHOP induction | Drug | Alemtuzumab, antibody |
Primary outcome
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
Time frame: average of 24 weeks (treatment duration)
A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab
2 secondary outcomes
rate of complete remissions
Time frame: at week 24 after initiation
Overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
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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 Truemper principal investigator
German High Grade Non Hodgkin´s Lymphoma Study Group
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alemtuzumab in people with Peripheral T-Cell Lymphoma, run by University of Göttingen.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy (time frame: average of 24 weeks (treatment duration)). 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 Mar 2013.