Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-07-31

Brief Summary

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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

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* 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

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Mycosis Fungoides Sezary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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alemtuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Abnormal renal or hepatic function
* Mycosis fungoides/Sezary syndrome in transformation
* HIV +
* HTLV-1 +
* Pregnancy
* Lactation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Brady E Beltran, MD

Role: PRINCIPAL_INVESTIGATOR

LACOGH - PERU

Locations

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Schering Peruana S.A.

Lima, Lima Province, Peru

Site Status RECRUITING

Countries

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Peru

Central Contacts

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Julia M Huamani, MD

Role: CONTACT

[email protected]

511-2227020

Facility Contacts

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Jesus A Arones, MD

Role: primary

[email protected]

99480078

References

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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.

Reference Type RESULT

PMID: 12543862 (View on PubMed)

Other Identifiers

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MF/SS

Identifier Type: -

Identifier Source: org_study_id