NCT00157274

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 3, 2007

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

April 2, 2007

Conditions

Mycosis FungoidesSezary Syndrome

Keywords

AlemtuzumabMycosis fungoidesSezary

Outcome Measures

Primary Outcomes (3)

  • Overall response

  • Time to relapse

  • Event free survival

Secondary Outcomes (1)

  • Toxicity

Interventions

alemtuzumabDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schering Peruana S.A.

Lima, Lima Province, 511, Peru

RECRUITING

Related Publications (1)

  • 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.

    PMID: 12543862RESULT

MeSH Terms

Conditions

Mycosis FungoidesSezary Syndrome

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, CutaneousLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Brady E Beltran, MD

    LACOGH - PERU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia M Huamani, MD

CONTACT

511-2227020juliahuamaniz@yahoo.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

July 1, 2005

Study Completion

July 1, 2008

Last Updated

April 3, 2007

Record last verified: 2005-09

Locations

PE(1)