Peripheral T-Cell LymphomaPhase 2NCT00441025
The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
A Phase 2 study testing Alemtuzumab in people with Peripheral T-Cell Lymphoma, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether the treatment of Alemtuzumab in combination with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first line treatment in patients with peripheral T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 15 to 65 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
- 4 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2006to Aug 2009
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of one of the following histologic types according to the WHO classification:
- Angioimmunoblastic T-cell lymphoma
- Extranodal NK/T-cell lymphoma,nasal type
- Enteropathy-type T-cell lymphoma
- Hepatosplenic gamma-delta T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
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- Anaplastic large-cell lymphoma,T/null cell,primary systemic type
- Peripheral T-cell lymphoma,not otherwise characterized
- Newly diagnosed,age 15-65 years.
- Complete work up for baseline evaluation and measurement (Appendix B)
- Patient's free written inform consent.
Who cannot join
- Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
- Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy
- Patients with poor performance status (PS;ECOG criteria of 3-4)(Appendix C).
- Serologic evidence of HCV and HCV RNA of chronic hepatitis.
- Serologic evidence of HBV and HBV RNA of chronic hepatitis.
- Patients with history of impaired cardiac status or myocardial infarction.
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- Patients with serum creatinine >= 1.8 mg/dl,bilirubin >= 1.5 times upper limit of normal range,SGOT or SGPT >= 3 times upper limit of normal range, unless due to tumor involvement.
- Patients with active uncontrolled infection,active non-malignant gastric or duodenal ulcer, uncontrolled diabetes mellitus or other severe medical conditions which would preclude aggressive cytotoxic chemotherapy.
- Active secondary malignancy.
- Pregnant or lactating women.
- Serious medical or psychiatric illness which prevent informed consent.
- Patients who are likely to lost to follow up (eg, unwilling or difficult to return,cannot be contacted).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma
The purpose of this study is to determine whether the treatment of Alemtuzumab in combination with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first line treatment in patients with peripheral T-cell lymphoma.
Read the detailed description
Peripheral T-cell lymphomas (PTCL) are more common in Asia than in Europe and United States (17-40% vs. 5-10%). Most studies reported a poorer prognosis for PTCL compared to B-cell non-Hodgkin's lymphomas (NHL).
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) is currently regarded as a standard chemotherapy regimen for patients with newly diagnosed NHL.
Alemtuzumab (Campath-1H) is a humanized monoclonal antibody that targets CD52, a cell surface protein present at high density on most normal and malignant B and T lymphocytes.Malignant T cells express particularly high numbers of CD52 cell surface markers (approximately 500,000 molecules/lymphocytes),T-cell malignancies may thus be particularly responsive to alemtuzumab.
As the response rate tend to be higher in patients newly diagnosed with PTCL, this study evaluates the efficacy of alemtuzumab in combination with CHOP administered as up-front therapy in patients newly diagnosed with PTCL in terms of response rate and overall survival.
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- Alemtuzumab
- Keywords
- MabCampath + CHOP in PTCL
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1 Alemtuzumab Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of alemtuzumab given in combination with CHOP in terms of the rates of objective response rate (ORR:complete remission[CR] and
partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)
in patients newly diagnosed with PTCL.
Secondary outcomes (1)
To determine the safety profiles of alemtuzumab given in combination with CHOP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startSep 2006
- Study completionAug 2009 (estimated)
Why it stopped: a lack of a potential patient.
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Surapol Issaragrisil, M.D.,Prof., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441025
- Sponsor's protocol ID
- TH 011002
- Status last verified
- Feb 2007
- First submitted
- 26 Feb 2007
- Last updated
- 25 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00441025
- Acronym / sponsor ID
- TH 011002
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- MabCampath + CHOP in PTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: a lack of a potential patient.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2006
- Study completion
- Aug 2009 (estimated)
- First posted
- 27 Feb 2007 (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.
The purpose of this study is to determine whether the treatment of Alemtuzumab in combination with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first line treatment in patients with peripheral T-cell lymphoma.
Detailed description
Peripheral T-cell lymphomas (PTCL) are more common in Asia than in Europe and United States (17-40% vs. 5-10%). Most studies reported a poorer prognosis for PTCL compared to B-cell non-Hodgkin's lymphomas (NHL).
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) is currently regarded as a standard chemotherapy regimen for patients with newly diagnosed NHL.
Alemtuzumab (Campath-1H) is a humanized monoclonal antibody that targets CD52, a cell surface protein present at high density on most normal and malignant B and T lymphocytes.Malignant T cells express particularly high numbers of CD52 cell surface markers (approximately 500,000 molecules/lymphocytes),T-cell malignancies may thus be particularly responsive to alemtuzumab.
As the response rate tend to be higher in patients newly diagnosed with PTCL, this study evaluates the efficacy of alemtuzumab in combination with CHOP administered as up-front therapy in patients newly diagnosed with PTCL in terms of response rate and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Alemtuzumab1 Alemtuzumab |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have a diagnosis of one of the following histologic types according to the WHO classification:
- Newly diagnosed,age 15-65 years.
- Complete work up for baseline evaluation and measurement (Appendix B)
- Patient's free written inform consent.
Key exclusion criteria (12 listed)
- Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
- Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy
- Patients with poor performance status (PS;ECOG criteria of 3-4)(Appendix C).
- Serologic evidence of HCV and HCV RNA of chronic hepatitis.
- Serologic evidence of HBV and HBV RNA of chronic hepatitis.
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 |
|---|---|---|
| Alemtuzumab | Drug | 1 |
Primary outcome
To determine the effectiveness of alemtuzumab given in combination with CHOP in terms of the rates of objective response rate (ORR:complete remission[CR] and
partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)
in patients newly diagnosed with PTCL.
1 secondary outcome
To determine the safety profiles of alemtuzumab given in combination with CHOP
Results and safety
The study was stopped early (reason given: a lack of a potential patient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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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.
Surapol Issaragrisil, M.D.,Prof. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
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 Mahidol University at 1 site in Thailand.
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 11 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: stopped early, as of the sponsor's last update on 25 Jun 2009. 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 Thailand. 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 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 was stopped early (reason given: a lack of a potential patient.). Results are not available in the source record.
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?
To determine the effectiveness of alemtuzumab given in combination with CHOP in terms of the rates of objective response rate (ORR:complete remission[CR] and. The study lists 3 primary outcomes in all. 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 25 Jun 2009; AzTrials last refreshed its copy on 8 Nov 2026.