Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/... | NCT00157274

Studies
Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

NCT00157274

Sponsor

Latin American Cooperative Onco-Haematology Group - Peru

Status

Unknown status

Last Update Posted

Apr 3, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Mycosis Fungoides
Sezary Syndrome

Interventions

alemtuzumab

Countries

Peru

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Jul 2008Estimated

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2007

Last Update Posted Date

Apr 3, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Latin American Cooperative Onco-Haematology Group - PeruOTHER

Collaborators

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
alemtuzumab	Drug

Measure	Description	Time Frame
Toxicity

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julia M Huamani, MD	Contact	511-2227020		juliahuamaniz@yahoo.es

Overall Officials

Name	Affiliation	Role
Brady E Beltran, MD	LACOGH - PERU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schering Peruana S.A.	Recruiting	Lima	Lima Province	511	Peru

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12543862	Result	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.

ID	Term
D016410	Lymphoma, T-Cell, Cutaneous
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

ID	Term
D009182	Mycosis Fungoides
D012751	Sezary Syndrome