RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas (NCT01198665) | Clinical Trial Compass
CompletedPhase 1/2
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
South Korea46 participantsStarted 2010-07
Plain-language summary
The urgent need for new effective therapy for T-cell lymphoma patients and promising results observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell lymphoma patients.
Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients.
Phase I
1. Primary objective
: To define the maximum tolerable dose
2. Secondary objective
* To evaluate the dose-limiting toxicity
* To evaluate the pharmacokinetics of RAD001
* Pharmacogenomic profiling
Phase II
1. Primary objective
: To evaluate the overall response rate
2. Secondary objective
* To estimate the time to progression
* To estimate overall survival
* Pharmacogenomic profiling
Who can participate
Age range
20 Years – 70 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.
. Adequate organ function as defined by the following criteria:
. At least one measurable lesion
. ECOG PS 0-2
. Informed consent
. Age 20 to 70 years old
Exclusion criteria
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
determination of the maximum tolerable dose and evaluation of response rate
Timeframe: Phase I for maximal tolerable dose and phase II for efficacy