NCT00254332

Brief Summary

This is a blood and tissue study to determine the effect of the drug called denileukin diftitox on the immune system cells that may be involved in patient response to their cutaneous t-cell lymphoma. Patients who are undergoing standard of care therapy with denileukin diftitox will be invited to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up to the first 4 cycles of denileukin diftitox.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 25, 2015

Status Verified

December 1, 2007

First QC Date

November 15, 2005

Last Update Submit

March 24, 2015

Conditions

Cutaneous T-cell LymphomaSezary SyndromeMycosis Fungoides

Keywords

Cutaneous T-cell LymphomaSezary SyndromeMycosis FungoidesDenileukin Diftitox

Eligibility Criteria

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

You may qualify if:

  • and older
  • diagnosed with CTCL
  • able and willing to provide informed consent
  • will be receiving denileukin diftitox per standard guidelines

You may not qualify if:

  • prior history of receiving Ontak
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsubrgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousSezary SyndromeMycosis Fungoides

Condition Hierarchy (Ancestors)

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

Study Officials

  • Larisa J. Geskin, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 16, 2005

Study Start

November 1, 2005

Study Completion

September 1, 2007

Last Updated

March 25, 2015

Record last verified: 2007-12

Locations

US(1)