CompletedPhase 2

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

United States49 participantsStarted 2004-03-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, ind…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants

Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months

Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants

Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months

Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class

Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months

Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events

Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months

Trial details

NCT IDNCT00211185

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2017-07-12

View on ClinicalTrials.gov More Lymphoma, T-Cell, Peripheral trials