At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed peripheral T-cell lymphoma of specified histologies (per REAL classification): unspecified PTCL, anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, or subcutaneous panniculitic T-cell lymphoma
- ✓Treatment-naïve except for prior radiation or a single cycle of CHOP
- ✓At least one clear-cut bidimensionally measurable site by physical exam and/or CT scan
- ✓Prior radiation therapy for localized disease allowed if completed at least 4 weeks before enrollment and not at mediastinal area or only site of measurable disease
- ✕Diagnosis of Mycosis Fungoides or Sezary Syndrome
- ✕Active Hepatitis B or C infection
- ✕Known HIV infection
- ✕Active infections requiring specific anti-infective therapy until resolved
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.
In Brief
A Phase 2 clinical trial evaluating Denileukin diftitox, Cyclophosphamide, and 4 other interventions for Lymphoma, T-Cell, Peripheral. Completed, enrolled 49 participants across 49 sites.
Detailed 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.
Study Details
Timeline
Interventions
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 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 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 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 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 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.