A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

NCT ID: NCT00211185

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-14
• Study Completion Date: 2009-12-23

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.

Conditions

Lymphoma, T-Cell, Peripheral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Denileukin diftitox in combination with CHOP

Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.

Group Type: EXPERIMENTAL

Denileukin diftitox

Intervention Type: DRUG

Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m\^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Doxorubicin

Intervention Type: DRUG

Doxorubicin will be administered IV at a dosage of 50 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Vincristine

Intervention Type: DRUG

Vincristine will be administered IV at a dosage of 1.4 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Prednisone

Intervention Type: DRUG

Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Pegfilgrastim

Intervention Type: OTHER

Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm\^2) for 2 days post-nadir.

Interventions

Denileukin diftitox

Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m\^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Intervention Type: DRUG

Doxorubicin

Doxorubicin will be administered IV at a dosage of 50 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Intervention Type: DRUG

Vincristine

Vincristine will be administered IV at a dosage of 1.4 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Intervention Type: DRUG

Prednisone

Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.

Intervention Type: DRUG

Pegfilgrastim

Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm\^2) for 2 days post-nadir.

Intervention Type: OTHER

Other Intervention Names

ONTAK; DAB389 IL-2; CHOP; CHOP; CHOP; CHOP; Neulasta; granulocyte-colony stimulating factor; G-CSF

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham Hematology and Oncology

Birmingham, Alabama, United States

Hematology Oncology Associates

Phoenix, Arizona, United States

Stanford Cancer Center

Stanford, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Ocala Oncology Center

Ocala, Florida, United States

Cancer Centers of Florida, P.A.

Ocoee, Florida, United States

Hematology Oncology Associates of IL

Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois, United States

Siouxland Hematology Oncology

Sioux City, Iowa, United States

Kansas City Cancer Centers

Lenexa, Kansas, United States

Dana Farber/ Harvard Cancer Center

Boston, Massachusetts, United States

New England Medical Center

Boston, Massachusetts, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Kansas City Cancer Centers

Kansas City, Missouri, United States

St. Joseph Oncology Inc.

Saint Joseph, Missouri, United States

Arch Medical Services

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Hematology Oncology Associates of NNJ

Morristown, New Jersey, United States

New Mexico Cancer Care Associates

Santa Fe, New Mexico, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Raleigh Hematology Oncology Associates

Cary, North Carolina, United States

Barrett Cancer Center-University of Cincinnati

Cincinnati, Ohio, United States

Greater Dayton Cancer Center

Kettering, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Texas Cancer Center

Arlington, Texas, United States

Marnie McFaddin Ward Cancer Center

Beaumont, Texas, United States

Texas Oncology,P.A.

Bedford, Texas, United States

Texas Cancer Center at Medical City

Dallas, Texas, United States

The Texas Cancer Center

Dallas, Texas, United States

El Paso Cancer Treatment Center

El Paso, Texas, United States

Texas Oncology

Fort Worth, Texas, United States

Texas Oncology

Garland, Texas, United States

Longview Cancer Center

Longview, Texas, United States

Allison Cancer Center

Midland, Texas, United States

West Texas Cancer Center

Odessa, Texas, United States

HOAST Medical Dr.

San Antonio, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Waco Cancer Care and Research Center

Waco, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Oncology and Hematology Associates of SW VA Inc.

Salem, Virginia, United States

Puget Sound Cancer Center

Edmonds, Washington, United States

Cancer Care Northwest

Spokane, Washington, United States

Northwest Cancer Specialists

Vancouver, Washington, United States

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 23278639 (View on PubMed)

Other Identifiers

#35

Identifier Type: -

Identifier Source: org_study_id