Clinical trial NCT00211185: A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
Official title: A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, T-Cell, Peripheral
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.


Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of peripheral T-cell lymphoma of one of the following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma.
* Treatment naïve except for prior radiation or a single cycle of CHOP.
* Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography.
* Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* At least 18 years of age.
* Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) \> or equal to 1000/microL, platelets \> or equal to 50,000/microL (25,000/MicroL if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin \> or equal to 8 g/dL.
* Adequate liver function, indicated by bilirubin \< or equal to 1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) \< or equal to 2 times the ULN or aspartate transaminase (AST) \< or equal to 2.0 times the ULN, and albumin \> or equal to 3.0 g/dL.
* Adequate renal function, indicated by serum creatinine \< or equal to 2.5 mg/dL.
* Women of childbearing potential and sexually active males agree to use an accepted and effective method of contraception.
* Able to give informed consent.

Exclusion Criteria:

* Diagnosis of Mycosis Fungoides or Sezary Syndrome.
* Active Hepatitis B or Hepatitis C infection.
* Known HIV infection (HIV testing is not required).
* Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections have resolved and any continuing treatment if appropriate is given on an outpatient basis.
* Previous doxorubicin therapy with cumulative dose of \>100 mg/m2.
* Left Ventricular Ejection Fraction (LVEF) \< 50%.
* Patients who are pregnant or breast-feeding.
* Prior invasive malignancies within past 5 years.
* Allergy to or history of allergy to diphtheria toxin or IL-2.
* Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within the past 3 months, arrhythmia) requiring ongoing treatment.
* Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days.
* Patients with deep vein thrombosis within 3 months.

Primary outcomes:
measure: Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
timeFrame: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
measure: Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants
timeFrame: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
measure: Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class
timeFrame: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
measure: Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events
timeFrame: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
Secondary outcomes:
measure: Overall Response in the Intent To Treat (ITT) Population
timeFrame: From the start of the treatment to the date of participant's death assessed up to 5 years 9 months
measure: Overall Response in the Efficacy Analyzable (EA) Population
timeFrame: From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months
measure: Duration of Response
timeFrame: From the date of the first documented CR (confirmed or unconfirmed) or PR until the date of first documentation of recurrent or PD or death, assessed up to 5 years 9 months
measure: Progression-Free Survival
timeFrame: From the date of first dose of study drug until date of first documentation of PD, recurrence, or death from any cause, assessed up to 5 years 9 months
measure: Percentage of Participants With Overall Survival
timeFrame: From date of randomization until death, or administrative close of study, whichever came first, assessed up to 5 years 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Chicago
country: United States
facility: Hematology Oncology Associates of IL
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Hematology Oncology
state: Iowa
city: Lenexa
country: United States
facility: Kansas City Cancer Centers
state: Kansas
city: Boston
country: United States
facility: Dana Farber/ Harvard Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Centers
state: Missouri
city: Saint Joseph
country: United States
facility: St. Joseph Oncology Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Arch Medical Services
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology Oncology Associates of NNJ
state: New Jersey
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Barrett Cancer Center-University of Cincinnati
state: Ohio
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Marnie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology,P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: The Texas Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Garland
country: United States
facility: Texas Oncology
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: San Antonio
country: United States
facility: HOAST Medical Dr.
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Waco Cancer Care and Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology and Hematology Associates of SW VA Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Center
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
Study officials:
References:
citation: Francine M. Foss, Nelida Sjak-Shie, Andre Goy, Ranjana Advani, Eric Jacobsen, and Mark Acosta A Phase II Study of Denileukin Diftitox (Ontak®) with CHOP Chemotherapy in Patients with Newly-Diagnosed Aggressive T-Cell Lymphomas, the CONCEPT Trial: Interim Analysis. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2461.
citation: Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. doi: 10.3109/10428194.2012.742521. Epub 2013 Jan 29.