Conditions: Lymphoma, T-Cell, Peripheral
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Denileukin diftitox intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisone intervention 6: Pegfilgrastim
Intervention descriptions: intervention 1: 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 2: 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 3: 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 4: 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 5: 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 6: 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.

Protocol document: