CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study (NCT01719835) | Clinical Trial Compass
UnknownPhase 2
CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study
United Kingdom87 participantsStarted 2012-03
Plain-language summary
This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.
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:
Previously untreated, histologically proven T-cell Lymphoma (any of the following):
* Peripheral T-cell lymphoma Not Otherwise Specified (PTCL NOS)
* Systemic Anaplastic large cell lymphoma (ALCL) ALK negative cases only
* Angioimmunoblastic T-cell lymphoma
* Hepatosplenic gamma/ delta T-cell lymphoma
* Enteropathy-associated T-cell lymphoma (EATL)
* Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV.
* Patient is male or female, and ≥18 years of age on the day of signing informed consent.
* WHO performance status 0, 1 or 2.
* Cross sectional imaging from a baseline contrast enhanced CT should show at least one measurable disease site that is at least 2 cm in longest diameter and measurable in two perpendicular dimensions with or without corresponding Fluorodeoxyglucose(FDG) avid lesions.
* Adequate cardiac function; formal assessment of left ventricular ejection fraction is only required if clinically indicated (a baseline echocardiogram should be done for patients with either hypertension, age \> 60 years or history of cardiac disease)
* Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.0x109/l; white blood cell count ≥ 3x109/l; platelets ≥ 100x109/l; haemoglobin (Hb) ≥ 9g/dl (can be post-transfusion), unless deemed disease related
* Adequate renal function: calculated creatinine clearance ≥50ml/minute.
* Adequate liver function: serum bilirubin ≤1.5x Uppe…
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
complete response rate (CR/CRu)
Timeframe: approximately 20 weeks after randomisation