NCT00050999

Brief Summary

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 1995

Longer than P75 for phase_4

Geographic Reach
9 countries

31 active sites

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

June 1, 1995

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 5, 2008

Status Verified

February 1, 2008

Enrollment Period

11.3 years

First QC Date

December 31, 2002

Last Update Submit

February 29, 2008

Conditions

Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Objective Rate of Response (ORR), defined as CR + CCR + PR

Secondary Outcomes (3)

  • Time-to-Treatment Failure

  • Time-to-Progression

  • Duration of Response

Interventions

ONTAKDRUG

Eligibility Criteria

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

You may qualify if:

  • Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
  • Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
  • Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
  • Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
  • Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
  • No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
  • No systemic infections;
  • Willingness to be randomized to a placebo treatment only arm;
  • ECOG performance status 0 or 1;

You may not qualify if:

  • Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Level 4 Department of Haematology Royal North Shore Hospital

Saint Leonard's, New South Wales, 2065, Australia

Location

Westmead Hospital, Department of Haematology

Westmead, New South Wales, 2145, Australia

Location

Mater Misericordiae Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

LKH Universitatsklinikum Graz

Graz, A-8036, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

Cross Cancer Centre

Edmonton, Alberta, Canada

Location

Hamilton Regional Cancer Center

Hamilton, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

Universitatsklinikum Charite

Berlin, Germany

Location

University of Erlangen

Erlangen, 91052, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

J.W. Goethe University Frankfurt

Frankfurt, 60590, Germany

Location

Universitatskrankenhaus Eppendorf

Hamburg, 20246, Germany

Location

Universitatsklinikum Mannheim

Mannheim, 68135, Germany

Location

Universitatsklinikum Munster

Münster, D-48149, Germany

Location

Sektion Dermatologische Onkologie

Tübingen, D-72076, Germany

Location

LUMC, Department of Dermatology

Leiden, 2333 ZA, Netherlands

Location

Medical Academy in Gdansk, Dept. of Hematology

Gdansk, 80-952, Poland

Location

Regional Oncological Center, Dept. of Chemotherapy

Lodz, 93-509, Poland

Location

Klinika Hematoonkologii Akademii Medycznej w Lublinie

Lublin, 20-950, Poland

Location

Oddzial Chorob Wewnetrznych i Hematologii

Poznan, 61-833, Poland

Location

The Medical University of Warsaw, Central Clinical Hospital

Warsaw, 02-097, Poland

Location

Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie

Warsaw, 02-781, Poland

Location

Blokhin Russian Cancer Research Center, RAMS

Moscow, Russia

Location

Burdenko Main Military Clinical Hospital

Moscow, Russia

Location

Central Research Institute of Skin and Venereal Diseases

Moscow, Russia

Location

Haematology Research Center RAMS

Moscow, Russia

Location

St. Petersburg Pavlov State Medical University

Saint Petersburg, Russia

Location

Samara Regional Clinical Hospital

Samara, 443095, Russia

Location

Universitatsspital Zurich Dermatologische Klinik

Zurich, Switzerland

Location

St. John's Institute of Dermatology

London, United Kingdom

Location

City Hospital

Nottingham, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (2)

  • Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

    PMID: 32632956DERIVED

  • Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.

    PMID: 23770157DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elyane Lombardy, M.D.

    Ligand Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 31, 2002

First Posted

January 3, 2003

Study Start

June 1, 1995

Primary Completion

September 1, 2006

Study Completion

December 1, 2006

Last Updated

March 5, 2008

Record last verified: 2008-02

Locations

AU(2)CA(3)RU(6)DE(8)PL(6)CH(1)US(1)NL(1)GB(3)