UnknownPhase 2

CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

China106 participantsStarted 2015-09

Plain-language summary

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.

Who can participate

Age range

16 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: * Newly diagnosed, histologically confirmed the following pathology subtype according to WHO 2008 classification: peripheral T Cell Lymphoma, not otherwise specified, angioimmunoblastic T cell lymphoma, ALK-negative anaplastic large cell lymphoma, enteropathy associated T cell lymphoma, subcutaneous panniculitis like T cell lymphoma, and hepatosplenic T-cell lymphoma. * ≥ 16 years of age. * Performance status of 2 or less. * Has no history of malignancy. * Has radiologically measurable disease. * Life expectancy ≥6 months. * Voluntarily sign an informed consent. Exclusion Criteria: * Pathology subtype with NK/T cell lymphoma, ALK positive-ALCL. * Primary central nervous system (CNS) lymphoma. * Previous systemic chemotherapy or local therapy. * Has undergone hematopoietic stem-cell transplantation (HSCT). * Has active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy. * Has uncontrollable cardiocerebrovascular, coagulative, autoimmune, or serious infectious disease. * Echocardiography shows left ventricular ejection fraction (LVEF) ≤ 50%. * Inadequate renal, hepatic or bone marrow function * Active liver or biliary disease. * Has other uncontrollable medical condition that may interfere with their participation in the study. * Woman in pregnancy or lactation. * Patient is known to be positive for Human immunodeficiency virus (HIV) infection.

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

Percentage of patients with complete remission （CR）

Timeframe: 6 months

Trial details

NCT IDNCT02533700

SponsorShandong Provincial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-05

View on ClinicalTrials.gov More Peripheral T-Cell Lymphoma, Not Otherwise Specified trials