Mycosis FungoidesPhase 2NCT00157274
Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
A Phase 2 study testing alemtuzumab in people with Mycosis Fungoides and Sezary Syndrome, run by Latin American Cooperative Onco-Haematology Group - Peru at 1 site in Peru.
Trial summary
The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- alemtuzumab
- How many people
- 20 participants
- Where
- 1 sitePeru
- Study dates
- Jul 2005to Jul 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Liver and renal function test less than twice upper label
- No active infection
- Written informed consent
- One to three regimens of previous chemotherapies
Who cannot join
- Abnormal renal or hepatic function
- Mycosis fungoides/Sezary syndrome in transformation
- HIV +
- HTLV-1 +
- Pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
Peru1 site, 1 recruiting
- Recruiting
Schering Peruana S.A.
Lima, Lima Province, 511
Jesus A Arones, MD, 99480078, alfredo_arones@hotmail.com
About this study
Official title: Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.
Read the detailed description
- 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
- Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
- Follow up for one year after last cycle of alemtuzumab.
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Being tested
- alemtuzumab
- Keywords
- Alemtuzumab, Mycosis fungoides, Sezary
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Time to relapse
Event free survival
Secondary outcomes (1)
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Onco-Haematology Group - Peru
- Sponsor type
- University, hospital or other
- Investigators
- Brady E Beltran, MD, Principal investigator, LACOGH - PERU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157274
- Sponsor's protocol ID
- MF/SS
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 3 Apr 2007
- Results posted
- No
Publications
Lundin J, Hagberg H, Repp R, Cavallin-Stahl E, Freden S, Juliusson G, Rosenblad E, Tjonnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. doi: 10.1182/blood-2002-09-2802. Epub 2003 Jan 23.
PubMed 12543862
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
- ClinicalTrials.gov ID
- NCT00157274
- Acronym / sponsor ID
- MF/SS
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Keywords
- Alemtuzumab, Mycosis fungoides, Sezary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Latin American Cooperative Onco-Haematology Group - PeruUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jul 2008 (estimated)
- First posted
- 12 Sep 2005 (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 investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.
Detailed description
- 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
- Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
- Follow up for one year after last cycle of alemtuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Above 18 years old
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Liver and renal function test less than twice upper label
- No active infection
- Written informed consent
Key exclusion criteria (6 listed)
- Abnormal renal or hepatic function
- Mycosis fungoides/Sezary syndrome in transformation
- HIV +
- HTLV-1 +
- Pregnancy
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 | – |
Primary outcome
Overall response
Time to relapse
Event free survival
1 secondary outcome
Toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2007.
- Results publication: PubMed 12543862Lundin J, Hagberg H, Repp R, Cavallin-Stahl E, Freden S, Juliusson G, Rosenblad E, Tjonnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. doi: 10.1182/blood-2002-09-2802. Epub 2003 Jan 23.
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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.
Brady E Beltran, MD principal investigator
LACOGH - PERU
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 Mycosis Fungoides and Sezary Syndrome, run by Latin American Cooperative Onco-Haematology Group - Peru at 1 site in Peru.
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 6 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 3 Apr 2007. 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 Peru. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia M Huamani, MD (511-2227020, juliahuamaniz@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response. 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?
On the ClinicalTrials.gov record for NCT00157274, which also lists 1 linked publication.
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 3 Apr 2007.