TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL
Status:
Recruiting
Trial end date:
2025-05-20
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital
Collaborators:
Central South University First Affiliated Hospital of Guangxi Medical University First Hospital of Jilin University Henan Cancer Hospital The First Affiliated Hospital of Nanchang University The First Hospital of Jilin University Tianjin First Central Hospital