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Study identifier: NCT06530576 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia

Condition: T-LGL Leukemia · NK-LGL Leukemia  ·  Sponsor: Institute of Hematology & Blood Diseases Hospital, China

PhasePhase 2
Planned participants48
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Shuhua Yi, Doctor  ·  86-22-23909106  ·  yishuhua@ihcams.ac.cn

Lugui Qiu, Doctor  ·  86-22-23909172  ·  qiulg@ihcams.ac.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Institute of Hematology & Blood Diseases HospitalTianjin, Tianjin Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06530576