Phase 2
N=49
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
Lymphoma, T-Cell, Peripheral
Bottom Line
View on ClinicalTrials.gov: NCT00211185 ↗Enrolled (actual)
49
Serious AEs
51.0%
Results posted
Mar 2020
Primary outcome: Primary: Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants — 63.3; 46.9; 40.8; 40.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Denileukin diftitox (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Prednisone (Drug); Pegfilgrastim (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants |
63.3; 46.9; 40.8; 40.8; 34.7; 34.7 | — |
| PRIMARY Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants |
55.1; 36.7; 30.6; 30.6; 30.6; 26.5 | — |
| PRIMARY Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class |
2.0; 8.2; 16.3; 24.5; 16.3; 12.2 | — |
| PRIMARY Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events |
1; 4; 1; 1; 1; 1 | — |
| SECONDARY Overall Response in the Intent To Treat (ITT) Population |
51.0; 4.1; 10.2; 6.1; 4.1; 4.1 | — |
| SECONDARY Overall Response in the Efficacy Analyzable (EA) Population |
67.6; 5.4; 13.5; 8.1; 5.4; 0.0 | — |
| SECONDARY Duration of Response |
29.7 | — |
| SECONDARY Progression-Free Survival |
12.4 | — |
| SECONDARY Percentage of Participants With Overall Survival |
63.3 | — |
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 3.0 g/dL.
- Adequate renal function, indicated by serum creatinine 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.
Data sourced from ClinicalTrials.gov (NCT00211185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.