Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma (NCT03730740) | Clinical Trial Compass
UnknownPhase 2
Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma
South Korea79 participantsStarted 2018-11-16
Plain-language summary
This study is to evaluate the efficacy and safety of lenalidomide maintenance therapy in patients with T-cell lymphoma who have undergone more than one treatment or relapsed after treatment and who acquired a response of more than a partial response after rescue chemotherapy. This is a phase 2 clinical trial.
Who can participate
Age range
65 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
. The following subtypes of T-cell lymphoma histologically diagnosed based on WHO classification:
. Relapse or progression after one or more previous therapies.
. Partial response or more to a salvage therapy and at least 4 cycles of that salvage therapy at the time of participation in the clinical study.
. Where autologous stem cell transplantation is unattainable due to poor physical conditions over 65 years of age or secondary transplantation is unattainable due to relapse after primary autologous stem cell transplantation.
. Non-pregnant female patients who satisfy the following:
. Male patients who can satisfy the following even if they are surgically infertile (with vasectomy):
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.
. 0 - 2 points in performance ability based on the classification of the eastern Cooperative Oncology Group (ECOG).
. Appropriate condition of bone marrow, kidney, and liver.
Exclusion criteria
. Anyone classified into a histological subtype outside the selection criteria;
. When autologous or allogenic stem cell transplantation is planned after salvage therapy;
. Patients with symptomatic or uncontrolled angina pectoris or congestive heart failure, arrhythmia requiring chemotherapy, or major hazards anticipated due to clinically significant myocardial infarction that occurred 6 months in prior to participating in this clinical test;
. In case of an infection exceeding Grade 2 under Common Terminology Criteria for Adverse Events, Version 4.03;
. Anyone with an accompanied disease that is severe and uncontrolled;
. Anyone with uncontrolled active Type B or C hepatitis (excluding healthy Type B hepatitis carriers who can be controlled by preventive antiviral agents);
. Anyone infected with human immunodeficiency virus (HIV);
. Anyone with allogenic organ transplantation or allogenic stem cell transplantation;