TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL (NCT04453345) | Clinical Trial Compass
UnknownPhase 2/3
TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL
China42 participantsStarted 2013-05-20
Plain-language summary
Large granular lymphocytic leukemia (LGLL) is a lymphoproliferative disease, with LGL infiltration in peripheral blood and bone marrow, hepatosplenomegaly, and cytopenia. Both T-LGLL and CLPD-NK are indolent disease and share similar biology and clinical course, and treated under the same strategy. So the investigators put them together as LGLL. The investigators used TPM regimen (thalidomide + prednison + methotrexate ) to treat LGLL since 2013, and 18/20 patients (90%) obtained clinical response, including 80% complete response. Adverse events (AE) of grade 3 and above are rare and safe. Therefore, the investigators designed this multicenter clinical trial to validate the efficacy of the TPM regimen in symptomatic T-LGLL and CLPD-NK.
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
. The gender of the patient is not limited, and the age is ≥18 years old;
. Must meet diagnostic criteria of T-LGLL or CLPD-NK according to WHO 2016 version;
. The patient is treatment naive or received single methotrexate less than 4 weeks and without response. If relapsed or refractory patients, the patients must be naive for both thalidomide and methotrexate.
. With LGLL treatment indications, it mainly includes (meets at least one of the following conditions):
. ANC \<0.5 × 10\^9 / L
. HGB \<100g / L or need red blood cell infusion to maintain
. PLT \<50 × 10\^9 / L
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 (CR) rate of TPM regimen
Timeframe: From date of TPM treatment until the date of complete response, assessed up to 100 months
Trial details
NCT IDNCT04453345
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Combining autoimmune diseases that require treatment
Exclusion criteria
. Unable to understand or follow the research procedure;
. Co-occurrent malignant tumors that has to be treated or course the symptom;
. Other serious diseases, such as liver, kidney, heart, lung, nerve or metabolic diseases, may impede the ability of patients to tolerate methotrexate, cyclophosphamide or cyclosporin A;
. ALAT / ASAT or alkaline phosphatase\> 3 times the normal value;
. Creatinine clearance \<60ml / min;
. Serological evidence of active infection of HIV, hepatitis C or hepatitis B;