OncoMatch/Clinical Trials/NCT06530576
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Is NCT06530576 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Thalidomide and methotrexate for t-lgl leukemia.
Treatment: Thalidomide and methotrexate — There is currently no standard first-line treatment for LGLL. The investigators used the TPM regimen (thalidomide + prednison + methotrexate ) to treat LGLL since 2020, enrolling a total of 54 patients and achieving an overall response rate (ORR) of 88.9% and a complete response (CR) rate of 75.9%. To further explore this hypothesis, the investigators designed this study to observe the efficacy of thalidomide monotherapy in patients with symptomatic LGLL. The investigators speculate that thalidomide plays a major role in the significant improvement of the TPM regimen compared to the MTX regimen. Patients with LGLL are treated with thalidomide at 50 to 100 mg. If the desired response is not achieved at specific time points, methotrexate is added. Thalidomide monotherapy is administered for up to 3 courses, and the TM regimen can also be used for up to 3 courses. The overall response rate with thalidomide monotherapy serves as the primary study endpoint.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
serum creatinine clearance ≥ 30 ml/min
Liver function
alt ≤ 3x uln, ast ≤ 3x uln, total bilirubin ≤ 2x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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