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

Eisai

Status and phase: Completed; Phase 2

Conditions: Lymphoma, T-Cell, Peripheral

Treatments: Drug: Doxorubicin; Other: Pegfilgrastim; Drug: Denileukin diftitox; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00211185

#35

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

49 participants in 1 patient group

Denileukin diftitox in combination with CHOP

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Denileukin diftitox

Other: Pegfilgrastim

Drug: Doxorubicin

Drug: Vincristine

Drug: Cyclophosphamide