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 range18 Years
SexALL
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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
✓. 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;
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
✕. 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;