Clinical trial NCT00050999: Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
Official title: A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-03
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

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

Primary outcomes:
measure: Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary outcomes:
measure: Time-to-Treatment Failure
measure: Time-to-Progression
measure: Duration of Response
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas, M.D. Anderson Cancer Center
state: Texas
city: St. Leonard's
country: Australia
facility: Level 4 Department of Haematology Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital, Department of Haematology
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
state: Queensland
city: Graz
country: Austria
facility: LKH Universitatsklinikum Graz
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Edmonton
country: Canada
facility: Cross Cancer Centre
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Regional Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Berlin
country: Germany
facility: Universitatsklinikum Charite
city: Erlangen
country: Germany
facility: University of Erlangen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt
country: Germany
facility: J.W. Goethe University Frankfurt
city: Hamburg
country: Germany
facility: Universitatskrankenhaus Eppendorf
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: Tubingen
country: Germany
facility: Sektion Dermatologische Onkologie
city: Leiden
country: Netherlands
facility: LUMC, Department of Dermatology
city: Gdansk
country: Poland
facility: Medical Academy in Gdansk, Dept. of Hematology
city: Lodz
country: Poland
facility: Regional Oncological Center, Dept. of Chemotherapy
city: Lublin
country: Poland
facility: Klinika Hematoonkologii Akademii Medycznej w Lublinie
city: Poznan
country: Poland
facility: Oddzial Chorob Wewnetrznych i Hematologii
city: Warsaw
country: Poland
facility: The Medical University of Warsaw, Central Clinical Hospital
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
city: Moscow
country: Russian Federation
facility: Blokhin Russian Cancer Research Center, RAMS
city: Moscow
country: Russian Federation
facility: Burdenko Main Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Research Institute of Skin and Venereal Diseases
city: Moscow
country: Russian Federation
facility: Haematology Research Center RAMS
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich Dermatologische Klinik
city: London
country: United Kingdom
facility: St. John's Institute of Dermatology
city: Nottingham
country: United Kingdom
facility: City Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Ligand Pharmaceuticals
name: Elyane Lombardy, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.