Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma (NCT01796002) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
Belgium, France, Germany421 participantsStarted 2013-01
Plain-language summary
Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).
Who can participate
Age range
18 Years – 80 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
. Males and females of 18 years of age to 80 years of age.
. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
. Able to adhere to the study visit schedule and other protocol requirements.
. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the World Health Organization (WHO) classification (2008;2011) may be included, whatever the Ann Arbor stage (I - IV):
. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
. Negative pregnancy test for Females of ChildBearing Potential (FCBP)
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
1
The primary efficacy endpoint is Progression Free Survival
Timeframe: 60 months
Trial details
NCT IDNCT01796002
SponsorThe Lymphoma Academic Research Organisation
. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
. Life expectancy of ≥ 90 days (3 months).
Exclusion criteria
. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
. Any condition that confounds the ability to interpret data from the study.
. Other types of lymphomas, e.g. B-cell lymphoma
. The following types of T cell lymphomas:
. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
. Extranodal T-cell/Natural Killer (NK)-cell lymphoma, nasal type
. Anaplastic large cell lymphoma, ALK-positive type
. Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)